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Kaimen Rigor review

Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma

Costa LJ, Bahlis NJ, Perrot A, Nooka AK, Lu J, Pawlyn C, Mina R, Caeiro G, Kentos A, Hungria V, Reece D, Niu T, Mylin AK, Hansen CT, Teipel R, Besemer B, Dimopoulos MA, Zamagni E, Yoshihara S, Kim K, Min CK, Geerts P, Van Leeuwen-Segarceanu E, Tyczynska A, Reguera JL, Johansson M, Hansson M, Turgut M, Grey M, Sidana S, Rodriguez-Otero P, Martinez-Lopez J, Hashmi H, Carson R, Kobos R, Sun W, Lantz K, Seifert A, Briseno-Toomey D, O'Rourke L, Rubin M, Vieyra D, Kang L, Mateos MV, MajesTEC-3 Trial Investigators.

DOI: 10.1056/nejmoa2514663
Record issued: 2026-08-10
Engine: 7.29.0
Exported: 2026-09-20

Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/16a102d4-a364-485a-a3ee-aa9186adb0ef is authoritative.

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ClaimsOverstated claim−0.5★
ReportingData & code availability not met−0.5★
ReportingKey resources partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.29.0Source: full text

Biggest issues

01Data and code not shared
highDisclosurereviewer-assessedFull detail
No data availability statement is present in the paper. No repository deposit or code sharing is mentioned. For a clinical trial, a data sharing statement is expected.
02Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
Tec-Dara may address the need for a highly effective regimen and community accessibility.
“Tec-Dara may address the need for a highly effective regimen and community accessibility.”
Discussion ¶3Find in source

Findings by category

01ArithmeticNone found 202OverreachOverstated conclusions 103AuthenticityData authenticity concerns 204DisclosureReporting gaps 05AvailabilityNone found 06Copyedit8 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

The paper is a methodologically sound phase 3 RCT with strong efficacy results, but it has several reporting gaps including missing data availability statement, lack of explicit IRB naming, and imprecise p-value reporting. These do not invalidate the findings but reduce transparency and reproducibility.

Three independent runs of the same model were synthesized; agreement was high on most dimensions. Disagreements on ethical approvals, key resources, and statistical analysis were resolved by weighing evidence and applying the scoring rules conservatively. The statistics verification covered 6 tests (all consistent); the citation check found no retracted or missing references. The claim audit flagged one overstated claim about community accessibility.

Numerical inconsistencies

None found

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Checked — nothing surfaced.

Recomputed 6 tests: 6 consistent, 0 inconsistent; 6 via agent-written checks.

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1
Recompute p-value for PFS hazard ratio (0.17) from its 95% CI (0.12-0.23) using pCI function.
“Estimated 36-month progression-free survival rate was 83.4% in the Tec-Dara group and 29.7% in the DPd/DVd group (HR, 0.17; 95% CI, 0.12–0.23; P<0.0001).”
Find in source
Taken as given: The 95% CI is two-sided and corresponds to the same test that produced the p-value; The HR is the estimate from the Cox model; The p-value is from the same stratified log-rank test (not the Wald test from the Cox model, but the CI-based p approximates it)
Method: pCI computes a two-sided p-value from the log(HR) and its standard error derived from the CI width, assuming a normal approximation.
How we recomputed it: pCI(0.17, 0.12, 0.23, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewers 1, 2
Recompute p-value for overall response risk ratio (1.18) from its 95% CI (1.09-1.27) using pCI.
“Rates of complete response or better (81.8% vs. 32.1%), overall response (89.0% vs. 75.3%), and MRD negativity (10−5; 58.4% vs. 17.1%) were significantly higher with Tec-Dara versus DPd/DVd (P<0.0001).”
Find in source
Taken as given: The risk ratio is the estimate from the stratified CMH test; The 95% CI is two-sided and corresponds to the same test that produced the p-value; The p-value is from the stratified CMH test
Method: pCI computes a two-sided p-value from the log(RR) and its standard error derived from the CI width, assuming a normal approximation.
How we recomputed it: pCI(1.18, 1.09, 1.27, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1
Recompute p-value for MRD negativity risk ratio (3.43) from its 95% CI (2.58-4.55) using pCI.
“Rates of complete response or better (81.8% vs. 32.1%), overall response (89.0% vs. 75.3%), and MRD negativity (10−5; 58.4% vs. 17.1%) were significantly higher with Tec-Dara versus DPd/DVd (P<0.0001).”
Find in source
Taken as given: The risk ratio is the estimate from the stratified CMH test; The 95% CI is two-sided and corresponds to the same test that produced the p-value; The p-value is from the stratified CMH test
Method: pCI computes a two-sided p-value from the log(RR) and its standard error derived from the CI width, assuming a normal approximation.
How we recomputed it: pCI(3.43, 2.58, 4.55, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Recompute p-value from HR and 95% CI for progression-free survival (primary endpoint).
“Estimated 36-month progression-free survival rate was 83.4% (95% CI, 78.2–87.4) with Tec-Dara versus 29.7% (95% CI, 23.6–36.0) with DPd/DVd (HR, 0.17; 95% CI, 0.12–0.23; P<0.0001)”
Find in source
Taken as given: The HR is on the log scale (ratio).; The 95% CI is two-sided and based on the Wald approximation.; The CI is for the HR, not the log-HR.
Method: pCI function from estimate and 95% CI on log scale.
How we recomputed it: pCI(0.17, 0.12, 0.23, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Recompute p-value from HR and 95% CI for time to worsening of symptoms.
“Estimated 36-month event-free rate for symptom worsening per MySIm-Q total symptom score was 75.6% (95% CI, 68.1–81.6) with Tec-Dara and 63.3% (95% CI, 54.7–70.6) with DPd/DVd (HR, 0.50; 95% CI, 0.34–0.72; P=0.0002)”
Find in source
Taken as given: The HR is on the log scale.; The 95% CI is two-sided and based on the Wald approximation.; The CI is for the HR.
Method: pCI function from estimate and 95% CI on log scale.
How we recomputed it: pCI(0.50, 0.34, 0.72, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 3
Primary PFS: HR 0.17, 95% CI 0.12-0.23, P<0.0001
“Estimated 36-month progression-free survival rate was 83.4% in the Tec-Dara group and 29.7% in the DPd/DVd group (HR, 0.17; 95% CI, 0.12–0.23; P<0.0001)”
Find in source
Taken as given: The HR is a ratio, so log=1; The CI is 95% and two-sided
Method: pCI function computes p-value from a ratio estimate and its 95% CI assuming log-normal distribution.
How we recomputed it: pCI(0.17, 0.12, 0.23, 1)

Overstated conclusions

2 findings · worst medium

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions overstated beyond the evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

9 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

overstatedReviewer 3
Tec-Dara may address the need for a highly effective regimen and community accessibility.
The paper demonstrates efficacy in a controlled trial setting, but community accessibility is not assessed; the study was conducted at specialized centers.
Evidence: No evidence on community administration or real-world feasibility is provided in the study.
“Tec-Dara may address the need for a highly effective regimen and community accessibility.”
Discussion ¶3Find in source
partialReviewers 1, 3
Tec-Dara is a synergistic immunotherapy combination.
The paper hypothesizes synergy based on daratumumab's immune effects, but the study does not provide mechanistic evidence of synergy; it only shows superior efficacy of the combination versus control.
Evidence: Discussion states daratumumab 'sensitizes the immune microenvironment... creating synergistic effects with teclistamab-mediated eradication of myeloma cells' but no direct synergy data are presented.
“This off-the-shelf, immunotherapy combination of teclistamab and daratumumab (Tec-Dara) is a potential therapeutic strategy to improve outcomes in second- or subsequent-line RRMM.”
IntroductionFind in source
partialReviewers 2, 3
Tec-Dara significantly improves overall survival compared to DPd/DVd.
Statistically significant (P<0.0001) but OS curves cross early, and the benefit is driven by later separation; RMST analysis supports benefit.
Evidence: Results, Efficacy: stratified log-rank test P<0.0001, 36-month OS rates 83.3% vs 65.0%, RMST difference 2.15 months (95% CI 0.54-3.77).
“Tec-Dara demonstrated a significantly lower risk of death than DPd/DVd (stratified log-rank test P<0.0001). Estimated 36-month overall survival rate was 83.3% (95% CI, 78.3–87.2) with Tec-Dara and 65.0% (95% CI, 58.8–70.5) with DPd/DVd”
ResultsFind in source
supportedReviewer 1
Tec-Dara demonstrated a statistically significant improvement in progression-free survival and overall survival over standard-of-care DPd/DVd as early as second-line.
The paper provides HR 0.17 (95% CI 0.12-0.23, P<0.0001) for PFS and a significant OS benefit (P<0.0001) with survival rate differences, fully supporting the claim.
Evidence: HR 0.17, 95% CI 0.12-0.23, P<0.0001 for PFS; OS P<0.0001 with 36-month rates 83.3% vs 65.0%.
Tec-Dara demonstrated a statistically significant improvement in progression-free survival and overall survival over standard-of-care DPd/DVd as early as second-line.
Abstractreviewer’s wording
supportedReviewer 1
Rates of complete response or better, overall response, and MRD negativity were significantly higher with Tec-Dara versus DPd/DVd.
The paper reports risk ratios and CIs: ≥CR RR 2.55 (95% CI 2.14-3.03), ORR RR 1.18 (95% CI 1.09-1.27), MRD negativity RR 3.43 (95% CI 2.58-4.55), all P<0.0001, supporting the claim.
Evidence: Table 2 provides response rates and risk ratios with CIs.
Rates of complete response or better (81.8% vs. 32.1%), overall response (89.0% vs. 75.3%), and MRD negativity (10−5; 58.4% vs. 17.1%) were significantly higher with Tec-Dara versus DPd/DVd (P<0.0001).
Table 2reviewer’s wording
supportedReviewer 1
The safety profile of Tec-Dara was well characterized, with a high frequency of adverse events, including treatment-emergent fatal events (7.1%).
The paper provides detailed safety tables (Table 3) and discusses adverse events, including grade 3/4 events, cytokine release syndrome, infections, and fatal events, supporting the claim.
Evidence: Table 3 shows adverse events frequencies; text reports deaths due to TEAEs (7.1% in Tec-Dara).
“Frequency of grade 3/4 (95.1% and 96.6%) and deaths due to treatment-emergent adverse events (7.1% and 5.9%) were similar between Tec-Dara and DPd/DVd, respectively.”
Table 3Find in source
supportedReviewers 2, 3
Tec-Dara significantly improves progression-free survival compared to DPd/DVd.
The primary endpoint met with HR 0.17 (95% CI 0.12-0.23, P<0.0001) and consistent across subgroups.
Evidence: Results, Efficacy: HR 0.17, 95% CI 0.12-0.23, P<0.0001, and Figure 1.
“Estimated 36-month progression-free survival rate was 83.4% in the Tec-Dara group and 29.7% in the DPd/DVd group (HR, 0.17; 95% CI, 0.12–0.23; P<0.0001)”
AbstractFind in source
supportedReviewer 2
Tec-Dara significantly improves response rates (≥CR, ORR, MRD negativity) compared to DPd/DVd.
All three secondary endpoints showed statistically significant improvements with risk ratios favoring Tec-Dara.
Evidence: Results, Efficacy: ≥CR risk ratio 2.55 (95% CI 2.14-3.03), ORR risk ratio 1.18 (95% CI 1.09-1.27), MRD negativity risk ratio 3.43 (95% CI 2.58-4.55), all P<0.0001.
Rates of complete response or better (81.8% vs. 32.1%), overall response (89.0% vs. 75.3%), and MRD negativity (10^{-5}; 58.4% vs. 17.1%) were significantly higher with Tec-Dara versus DPd/DVd (P<0.0001)
Abstractreviewer’s wording
supportedReviewer 2
The safety profile of Tec-Dara is manageable with established protocols.
Adverse events are common but manageable with supportive care; fatal events are similar between groups, and infection management improved with protocol amendments.
Evidence: Results, Safety: Grade 3/4 AEs 95.1% vs 96.6%, deaths due to treatment-emergent AEs 7.1% vs 5.9%, and discussion of infection prevention after protocol amendment.
“Nearly all patients experienced a grade 3 or higher adverse event (7.1% deaths due to treatment-emergent adverse events), most of which were cytopenias and infections. These events can be controlled with established immunoglobulin replacement and infection prevention and treatment protocols.”
DiscussionFind in source

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

ADEQUATESurrogate endpoint
Primary endpoint is progression-free survival (a clinical outcome) and overall survival is also reported; the efficacy claim does not rest on a surrogate or biomarker.
“The primary endpoint was progression-free survival by independent review committee.”
Find in source
ADEQUATEEffect size
Large effect size: HR 0.17 for PFS, 36-month PFS rates 83.4% vs 29.7%; OS also significantly improved with 36-month rates 83.3% vs 65.0%.
“Estimated 36-month progression-free survival rate was 83.4% in the Tec-Dara group and 29.7% in the DPd/DVd group (HR, 0.17; 95% CI, 0.12–0.23; P<0.0001).”
Find in source

Data authenticity concerns

1 finding · worst low

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Other integrity concernAssessed

2 integrity concerns flagged (0 high).

lowother
The paper states that after reinforced immunoglobulin guidance, only 1 infection-related death occurred, but the denominator of patients treated after the amendment is not provided, making it difficult to assess the effectiveness of the intervention.
Twelve of 13 infection-related deaths on Tec-Dara occurred ≤6 months following treatment initiation, before the implementation of reinforced protocol-specified immunoglobulin replacement; 1 infection-related death was reported thereafter.
Results ¶4reviewer’s wording
lowother
The 36-month PFS rate (83.4%) and OS rate (83.3%) in the Tec-Dara group are nearly identical, which is unusual. This may be due to the fact that most patients who progress do not die within the follow-up period, but it warrants explanation.
Estimated 36-month progression-free survival rate was 83.4% ... Estimated 36-month overall survival rate was 83.3%
Abstractreviewer’s wording

Reporting gaps

2 findings · worst high

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data and code not sharedAssessed
Key resources under-identified (antibodies, cell lines, RRIDs)Assessed

Eight Dimensions6 pass · 1 warn · 1 fail

Prior work is cited (MajesTEC-1, APOLLO, CASTOR, CARTITUDE-4). The rationale for combining teclistamab and daratumumab is based on synergistic mechanisms (daratumumab enhances CD8+ T-cell cytotoxicity). The study addresses the need for off-the-shelf, highly effective regimens in RRMM, acknowledging the limitations of prior treatments.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific foundation by citing prior studies, providing a logical rationale for the combination, and addressing limitations of existing treatments.

Evidence

“Teclistamab, a bispecific antibody targeting CD3×BCMA, demonstrated deep and durable responses in heavily pretreated RRMM in the phase 1/2 MajesTEC-1 study.”

IntroductionFind in source

“This off-the-shelf, immunotherapy combination of teclistamab and daratumumab (Tec-Dara) is a potential therapeutic strategy to improve outcomes in second- or subsequent-line RRMM.”

IntroductionFind in source

paraphrase[Introduction]

“Treating relapsed/refractory MM is increasingly challenging, as the evolving frontline landscape complicates second-line treatment selection. Challenges are compounded by limited effective salvage treatment options and high attrition.”

PASSReviewer 2· 90% conf

Scientific premise is well-established with prior work cited and logical rationale for the combination.

Evidence

“Teclistamab, a bispecific antibody targeting CD3×BCMA, demonstrated deep and durable responses in heavily pretreated RRMM in the phase 1/2 MajesTEC-1 study.”

Introduction ¶3Find in source

“In addition to direct on-tumor effects, daratumumab sensitizes the immune microenvironment by depleting immunosuppressive T-cells and enhancing CD8+ T-cell cytotoxicity, creating synergistic effects with teclistamab-mediated eradication of myeloma cells.”

Introduction ¶3Find in source

absence[Introduction]

Limitations of prior research are not systematically addressed

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific premise by citing prior research, providing a logical rationale for the combination, and addressing limitations of prior treatments.

Evidence

“Teclistamab, a bispecific antibody targeting CD3×BCMA, demonstrated deep and durable responses in heavily pretreated RRMM in the phase 1/2 MajesTEC-1 study.”

Introduction ¶3Find in source

“daratumumab sensitizes the immune microenvironment by depleting immunosuppressive T-cells and enhancing CD8+ T-cell cytotoxicity, creating synergistic effects with teclistamab-mediated eradication of myeloma cells.”

Introduction ¶4Find in source

“off-the-shelf and highly effective regimens are needed to fully address patient needs.”

Introduction ¶2Find in source

Randomization is 1:1 with stratification factors, but the method of sequence generation is not described. The study is explicitly open-label. Power analysis is detailed (90% power, 560 patients, 335 events). Inclusion/exclusion criteria are clearly defined. The ITT population is used for efficacy, and missing data handling is referenced in the supplementary appendix.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodINADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

The study design is adequately described, with power analysis, eligibility criteria, and open-label design specified. Randomization method is stated but not detailed (stratified 1:1).

Evidence

“Patients were randomly assigned 1:1 to receive Tec-Dara or investigator’s choice of standard-of-care regimens of DPd/DVd.”

MethodsFind in source

paraphrase[Methods, Study design and oversight]

“This multicenter, open-label, study randomized patients...”

“A sample size of 560 patients and the occurrence of 335 progression-free survival events were estimated to provide 90% power to detect a 30% lower risk of disease progression or death with Tec-Dara versus DPd/DVd at an overall 2-sided alpha level of 0.05.”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

Randomization, stratification, power analysis, and eligibility criteria are adequately reported. The open-label design is stated.

Evidence

“Patients were randomly assigned 1:1 to receive Tec-Dara or investigator’s choice of standard-of-care regimens of DPd/DVd.”

MethodsFind in source

Statistical analysisFind in source

paraphrase[Methods, Study design and oversight]

“This multicenter, open-label, study randomized patients...”

PASSReviewer 3· 85% conf

The study design is appropriate for a phase 3 RCT with adequate randomization, open-label, power analysis, inclusion/exclusion criteria, and ITT analysis. Randomization method is not fully detailed.

Evidence

“Patients were randomly assigned 1:1 to receive Tec-Dara or investigator’s choice of standard-of-care regimens of DPd/DVd.”

Methods ¶1Find in source

paraphrase[Methods, Study design and oversight, paragraph 1]

“This multicenter, open-label, study randomized patients...”

Statistical analysis ¶1Find in source

Table 1 reports median age, race, ECOG performance status, ISS stage, prior lines, and other characteristics. Sex is reported as percentage male. Health status is captured via ECOG and ISS. Demographics include race, age, and geographic region. Single-sex justification is not applicable as both sexes are included.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Biological variables (sex, age, health status, demographics) are comprehensively reported in Table 1.

Evidence

paraphrase[Table 1]

“Male sex, no. (%) 156 (53.6) 169 (57.1) 325 (55.4)”

paraphrase[Table 1]

“Median age (range), yr 64 (36–88) 63 (25–84) 64 (25–88)”

paraphrase[Table 1]

“Race, no. (%) White 190 (65.3) 194 (65.5) 384 (65.4)”

PASSReviewer 2· 90% conf

Demographics including age, sex, race, ECOG performance status, ISS stage, and prior therapy are reported in Table 1.

Evidence

paraphrase[Table 1]

“Median age (range), yr | 64 (36–88) | 63 (25–84) | 64 (25–88) | Male sex, no. (%) | 156 (53.6) | 169 (57.1) | 325 (55.4)”

PASSReviewer 3· 95% conf

Patient demographics including sex, age, race, ECOG performance status, and ISS stage are reported in Table 1. Both sexes are included, so no sex justification is needed.

Evidence

paraphrase[Table 1]

“Male sex, no. (%) 156 (53.6)”

paraphrase[Table 1]

“Median age (range), yr 64 (36–88)”

paraphrase[Table 1]

“Race, no. (%) White 190 (65.3)... ECOG performance status score... International Staging System stage...”

The paper reports that local independent ethics committees and IRBs approved the protocol, that the study was conducted per Declaration of Helsinki and ICH-GCP, and that all patients gave written informed consent.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

Ethical approval and consent are described, but the IRB/ethics committee is not named individually, which is considered inadequate.

Evidence

“Local independent ethics committees and institutional review boards at each study site approved the study protocol and amendments.”

MethodsFind in source

“All patients provided written informed consent.”

MethodsFind in source

“The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation guidelines for Good Clinical Practice, and country-specific regulations.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethics committee approval, informed consent, and regulatory compliance are explicitly stated.

Evidence

paraphrase[Methods, Study design and oversight]

“Local independent ethics committees and institutional review boards at each study site approved the study protocol and amendments. All patients provided written informed consent.”

“The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation guidelines for Good Clinical Practice, and country-specific regulations.”

MethodsFind in source

PASSReviewer 3· 95% conf

Ethics approval from local IRBs, written informed consent, and compliance with Declaration of Helsinki and ICH-GCP are explicitly stated.

Evidence

“Local independent ethics committees and institutional review boards at each study site approved the study protocol and amendments.”

Methods ¶1Find in source

“All patients provided written informed consent.”

Methods ¶2Find in source

“The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation guidelines for Good Clinical Practice, and country-specific regulations.”

Methods ¶1Find in source

Reagents_identified is adequate (teclistamab, daratumumab, pomalidomide, bortezomib, dexamethasone with dose/schedule, sponsor Johnson & Johnson). Software_tools_identified is inadequate: only clonoSEQ is named without version, and no statistical software is mentioned. All other sub-criteria are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 70% conf

Investigational products are described with dosing regimens but manufacturer/source is not explicitly stated. No custom software is identified, and software tools are not reported for analysis.

Evidence

“The Tec-Dara group received 28-day cycles of teclistamab at 1.5 mg/kg weekly in cycle 1 following 2 step-up doses of 0.06 and 0.3 mg/kg; 1.5 mg/kg weekly in cycle 2; 3 mg/kg every 2 weeks in cycles 3 to 6; and 3 mg/kg every 4 weeks from cycle 7 onward”

MethodsFind in source

paraphrase[Methods, Study treatments]

“Subcutaneous daratumumab was dosed per the approved dosing schedule.”

“MRD was assessed in bone marrow aspirates by next-generation sequencing (NGS; clonoSEQ; Adaptive Biotechnologies)”

MethodsFind in source

FAILReviewer 2· 80% conf

Key resources are inadequately identified: the investigational drugs (teclistamab, daratumumab) are named but not linked to a manufacturer or catalog number, and no statistical software is reported.

Evidence

paraphrase[Methods, Study treatments]

“The Tec-Dara group received 28-day cycles of teclistamab at 1.5 mg/kg weekly... Subcutaneous daratumumab was dosed per the approved dosing schedule.”

absence[Methods, Statistical analysis]

Statistical software not mentioned

WARNReviewer 3· 80% conf

The investigational drugs are identified with manufacturer and dosing regimen, but statistical software is not identified, and the clonoSEQ assay is partially identified.

Evidence

Methods ¶2Find in source

paraphrase[Methods, Study treatments, paragraph 2]

“Subcutaneous daratumumab was dosed per the approved dosing schedule.”

absence[Methods, Statistical analysis]

Statistical software is not named.

The paper uses stratified log-rank test, Cox regression, and Cochran-Mantel-Haenszel tests. Exact p-values are reported for some outcomes (P=0.0002) but not for the primary endpoint (P<0.0001). Effect sizes are reported with 95% CIs. The data presentation includes Kaplan-Meier curves and tables. No statistical software is mentioned. No arithmetic errors were detected in the reported numbers.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 80% conf

Statistical tests are named and effect sizes with CIs are reported. However, p-values are reported as thresholds (e.g., P<0.0001) rather than exact values, and statistical software is not identified.

Evidence

“Time-to-event endpoints were compared between groups using a 2-sided stratified log-rank test.”

Statistical analysisFind in source

“Estimated 36-month progression-free survival rate was 83.4% in the Tec-Dara group and 29.7% in the DPd/DVd group (HR, 0.17; 95% CI, 0.12–0.23; P<0.0001).”

AbstractFind in source

paraphrase[Abstract, Results]

“Rates of complete response or better (81.8% vs. 32.1%), overall response (89.0% vs. 75.3%), and MRD negativity (10−5; 58.4% vs. 17.1%) were significantly higher with Tec-Dara versus DPd/DVd (P<0.0001).”

PASSReviewer 2· 85% conf

Statistical tests are named, effect sizes with CIs are reported, and data presentation is adequate. However, exact p-values are not always provided (e.g., P<0.0001) and statistical software is not identified.

Evidence

paraphrase[Methods, Statistical analysis]

“Time-to-event endpoints were compared between groups using a 2-sided stratified log-rank test. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using a stratified Cox regression model.”

“Tec-Dara resulted in a significantly lower risk of disease progression or death than DPd/DVd (P<0.0001)”

ResultsFind in source

paraphrase[Results, Efficacy]

“Estimated 36-month progression-free survival rate was 83.4% (95% CI, 78.2–87.4) with Tec-Dara versus 29.7% (95% CI, 23.6–36.0) with DPd/DVd (HR, 0.17; 95% CI, 0.12–0.23)”

PASSReviewer 3· 85% conf

Statistical tests are named, effect sizes with CIs are reported, and data presentation is clear. However, exact p-values are not reported (only thresholds) and statistical software is not identified.

Evidence

“Time-to-event endpoints were compared between groups using a 2-sided stratified log-rank test.”

Statistical analysis ¶3Find in source

paraphrase[Results, Efficacy, paragraph 1]

“P<0.0001”

“HR, 0.17; 95% CI, 0.12–0.23; P<0.0001”

AbstractFind in source

The paper does not include any statement about data availability, repository deposit, or code sharing. The only mention of data access is the trial registration and supplementary materials at NEJM.org, but no explicit data sharing statement.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositNOT REPORTED

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 90% conf

No data availability statement is present; the paper does not indicate where data can be accessed. No code is shared.

Evidence

absence[Entire paper]

No data availability statement found.

FAILReviewer 2· 90% conf

No data availability statement is present; no repository deposit, accession numbers, or code sharing are mentioned.

Evidence

absence[Entire text]

No data availability statement in the paper

FAILReviewer 3· 95% conf

No data availability statement is present in the paper. No repository deposit or code sharing is mentioned. For a clinical trial, a data sharing statement is expected.

Evidence

absence[Entire manuscript]

No data availability statement is found.

Methods are comprehensive. Trial registration is provided (NCT05083169). All key outcomes are reported. Limitations including open-label design, COVID-19 pandemic context, and early infectious deaths are discussed. Conclusions are consistent with the data. Funding and conflict of interest are disclosed. No explicit reporting guideline (e.g., CONSORT) is mentioned, but the paper follows standard clinical trial reporting.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent: methods are detailed, trial is registered, outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. The only omission is a reporting guideline reference.

Evidence

paraphrase[Abstract]

“ClinicalTrials.gov identifier: NCT05083169 (https://clinicaltrials.gov/ct2/show/NCT05083169)”

“MajesTEC-3 enrollment began during the COVID-19 pandemic, before the establishment of optimal infection prevention strategies for patients receiving BCMA-directed therapy.”

DiscussionFind in source

“Johnson & Johnson sponsored the study and funded the medical writing assistance.”

MethodsFind in source

PASSReviewer 2· 90% conf

Methods are detailed, trial registered, all outcomes reported, limitations discussed, conclusions proportional, and funding/COI disclosed. Reporting guideline (CONSORT) is not referenced.

Evidence

paraphrase[Abstract]

“ClinicalTrials.gov identifier: NCT05083169”

“MajesTEC-3 enrollment began during the COVID-19 pandemic, before the establishment of optimal infection prevention strategies for patients receiving BCMA-directed therapy.”

DiscussionFind in source

“Johnson & Johnson sponsored the study and funded the medical writing assistance.”

MethodsFind in source

PASSReviewer 3· 85% conf

Methods are detailed, trial is registered, all outcomes are reported, limitations are discussed, conclusions are proportional to the evidence, and funding/COI are disclosed. However, no reporting guideline is referenced.

Evidence

paraphrase[Abstract, last sentence]

“ClinicalTrials.gov identifier: NCT05083169”

“Only a few patients on MajesTEC-3 had received prior anti-CD38 therapy”

Discussion ¶4Find in source

“Johnson & Johnson sponsored the study and funded the medical writing assistance.”

Methods ¶2Find in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

ClinicalTrials.gov

NCT05083169

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 41 references by DOI: 28 verified — 13 no DOI (shown, not verified).

NO DOI
Real-world assessment of treatment patterns and outcomes in patients with lenalidomide-refractory relapsed/refractory multiple myeloma from the Optum database
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
TECVAYLI® (teclistamab-cqyv) injection, for subcutaneous use [package insert]
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Long-term follow-up from the phase 1/2 MajesTEC-1 trial of teclistamab in patients with relapsed/refractory multiple myeloma
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) [package insert]
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
DARZALEX® (daratumumab) injection, for intravenous use [package insert]
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Dosing and administration guide: DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and DARZALEX® (daratumumab)
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
MagnetisMM-5: An open-label, multicenter, randomized phase 3 study of elranatamab as monotherapy and in combination with daratumumab in patients with relapsed/refractory multiple myeloma
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
PB2133: Trial In Progress: Linker-MM3, a phase 3, open-label, randomized study of linvoseltamab versus elotuzumab, pomalidomide, and dexamethasone (EPd) in relapsed/refractory multiple myeloma (RRMM)
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
MonumenTAL-3: Phase 3 trial of talquetamab + daratumumab ± pomalidomide versus daratumumab + pomalidomide + dexamethasone in relapsed/refractory multiple myeloma following ≥1 prior line of therapy
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Efficacy and safety of teclistamab in relapsed refractory multiple myeloma: long-term follow-up from a real world multi-institutional cohort
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Risk of infections in multiple myeloma patients treated with bispecific antibodies
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Dosing patterns and early safety and effectiveness outcomes in patients with multiple myeloma treated with teclistamab in the community setting
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

2 data/code links checked; 1 live.

datahttps://clinicaltrials.gov/ct2/show/NCT05083169LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://www.nejm.org/UNVERIFIEDHTTP 403
Liveness indeterminate — content not checked.

Copyediting

8 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 8 minor suggestions below.

8 copyedit issues flagged: mostly consistency, grammar, clarity.

MINORconsistencyAbstract title
“Teclistamab plus Daratumumab in Relapsed Refractory Multiple Myeloma”
→ Consider adding a hyphen or comma: 'Relapsed/Refractory' or 'Relapsed, Refractory'
This is a minor style point; the paper is otherwise clear.
MINORconsistencyAbstract
“relapsed refractory multiple myeloma”
→ relapsed/refractory multiple myeloma
Hyphen or slash for consistency with rest of text.
MINORgrammarResults, paragraph 1
“The median duration of treatment was twice as long for Tec-Dara versus DPd/DVd (32.4 vs. 16.1 months, respectively).”
→ Consider rephrasing to 'twice that for DPd/DVd' for clarity.
Minor style issue.
MINORclarityMethods, Study treatments
“The teclistamab dosing schedule aligns with the approved daratumumab schedule to increase dosing convenience.”
→ Clarify that the schedule is aligned for convenience, not that it is the same as approved.
Potential ambiguity.
MINORgrammarAbstract, last sentence
“with a high frequency of adverse events, that included treatment-emergent fatal events (7.1%)”
→ Change 'that' to 'which' or restructure: 'including treatment-emergent fatal events (7.1%)'
Comma before 'that' is incorrect; 'which' is appropriate for a non-restrictive clause.
MINORclarityAbstract, line 4
“44.2%/15.9%”
→ Write as '44.2% and 15.9%' for clarity
Percentages separated by a slash may be ambiguous.
MINORconsistencyResults, Efficacy, paragraph 4
“Estimated 36-month overall survival rate was 83.3% (95% CI, 78.3–87.2) with Tec-Dara and 65.0% (95% CI, 58.8–70.5) with DPd/DVd (; ).”
→ Remove the empty parentheses '();' or insert the correct figure reference.
There is a stray '; )' that appears to be a placeholder for a figure citation.
MINORpunctuationMethods, Study treatments, paragraph 3
“Patients who discontinued ≥1 component of study treatment could continue to receive other components, as assigned.”
→ Consider adding a comma after 'discontinued' for clarity: 'Patients who discontinued ≥1 component of study treatment could continue to receive other components, as assigned.'
The current punctuation is acceptable but could be slightly clearer.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published paper is robust in its core methodology but has notable reporting gaps. A critical reader should weigh the absence of a data availability statement and the lack of exact p-values as limitations. An erratum could address the data availability statement, IRB naming, and software identification; the statistical reporting, while imprecise, does not threaten the conclusions. The paper would benefit from a correction to improve transparency, but the findings are not invalidated.

1.
HIGHdata code
Add a data availability statement specifying how to access de-identified patient data (e.g., via a managed-access platform like YODA or Vivli, or through the sponsor).
The paper has no data sharing statement, which is a major transparency gap for a clinical trial and may warrant an erratum.
2.
HIGHethics
Include the name(s) of the specific ethics committee(s) or IRB(s) that approved the study, along with protocol numbers, in the Methods section.
The current generic statement lacks specificity expected for a published trial; a correction would improve transparency.
3.
HIGHstatistics
Report exact p-values (e.g., to 3 significant figures) instead of thresholds like P<0.0001 in the abstract and results.
Threshold-only p-values are considered imprecise reporting; exact values improve reproducibility and reader confidence.
4.
HIGHother
State the manufacturer/source of the investigational drugs (teclistamab and daratumumab) in the Methods section.
The drugs are the key resources; missing manufacturer information is a deficiency that should be corrected.
5.
HIGHstatistics
Identify the statistical software used (e.g., SAS version 9.4, R version 4.2) in the Statistical analysis section.
Software identification is standard for reproducibility; its absence is a notable omission.
6.
MEDIUMreporting
Mention adherence to a reporting guideline (e.g., CONSORT 2010) and include a completed checklist, or note that the trial follows CONSORT.
Referencing the guideline is standard practice for RCTs and would improve reporting completeness.
7.
MEDIUMother
Describe the method of random sequence generation (e.g., computer-generated random numbers, block sizes) in the Methods section.
The current description is vague; specifying the method would improve reproducibility.
8.
MEDIUMcopyedit
Fix the stray empty parentheses '();' in the Results section (36-month OS estimate) by removing or inserting the correct figure citation.
This appears to be a placeholder error that should be corrected in the published text.
9.
LOWcopyedit
Change 'that' to 'which' in the sentence about adverse events in the abstract: 'with a high frequency of adverse events, which included treatment-emergent fatal events (7.1%)'.
Grammatical correction for a non-restrictive clause.
10.
LOWcopyedit
Use consistent terminology: 'relapsed/refractory' with a slash throughout the abstract and text.
Minor consistency issue; the abstract currently uses 'relapsed refractory' without a slash.
11.
LOWother
Consider providing the denominator of patients treated after the reinforced immunoglobulin guidance to allow assessment of infection-related death rate.
The paper reports that only 1 infection-related death occurred after the guidance, but without the denominator the effectiveness is unclear.

Full text (41,055 chars)Analyzed: Aug 10, 2026

RigorReviewer 1

RigorReviewer 2

RigorReviewer 3

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

ReproducibilityLink verification (liveness + content)· no model (rule-based)

PreregistrationDeterministic check· no model (rule-based)

The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”

How stars are deducted

Reporting — 8 dimensionseach dimension that fully fails−½★
each dimension partially met−¼★
Statistics · Integrity · Claimseach serious problem−1★
each medium problem−½★
Citationseach retracted or unverifiable reference−¼★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.

The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma

DOI

10.1056/nejmoa2514663

Record issued

2026-08-10

Engine

7.29.0

Exported

2026-09-20