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
- 2026-08-15
- Engine
- 7.39.0
- Exported
- 2026-09-22
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/36ea0ba7-071b-4342-82eb-189c12d9e261 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- ReportingData & code availability partially met−0.25★
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.
This is a well-conducted phase 3 randomized controlled trial with rigorous design, clear reporting of ethics, demographics, and statistical methods. The main weaknesses are the absence of a data availability statement and lack of explicit statistical software identification, both minor reporting gaps.
Both reviewers classified the study as interventional, and this was adopted. The evaluation covered all eight dimensions; non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded. The reviewers agreed on all dimension statuses, with minor checklist discrepancies that did not affect outcomes.
Numerical inconsistencies
1 finding · worst lowValues 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.
- Internal contradictions in the reported numbersAssessed
Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks.
- CONSISTENTreported p < .001 · recomputed p = <.001Reviewers 1, 2PFS hazard ratio p-value from CI
“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).”
Taken as given: The HR is 0.17 with 95% CI 0.12-0.23.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Compute p-value from HR and CI using the formula for the log hazard ratio.How we recomputed it: pCI(0.17, 0.12, 0.23, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1Overall response risk ratio p-value from CI
“A significant difference was also seen with overall response rate (89.0% vs. 75.3%), with a risk ratio of 1.18 (95% CI, 1.09–1.27; ).”
Taken as given: The risk ratio is 1.18 with 95% CI 1.09-1.27.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Compute p-value from RR and CI using the formula for the log risk ratio.How we recomputed it: pCI(1.18, 1.09, 1.27, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1MRD negativity risk ratio p-value from CI
“MRD-negativity rate (10 −5 ) was higher with Tec-Dara versus DPd/DVd (58.4% vs. 17.1%) with a risk ratio of 3.43 (95% CI, 2.58–4.55; ).”
Taken as given: The risk ratio is 3.43 with 95% CI 2.58-4.55.; The CI is two-sided at 95%.; The p-value is two-tailed.Method: Compute p-value from RR and CI using the formula for the log risk ratio.How we recomputed it: pCI(3.43, 2.58, 4.55, 1) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2P-value for overall survival log-rank test
“Tec-Dara demonstrated a significantly lower risk of death than DPd/DVd (stratified log-rank test P<0.0001).”
Taken as given: The reported p-value is from a stratified log-rank test.; The test statistic is approximately normal under the null.; The p-value is two-sided.Method: Approximated the p-value using a normal distribution, assuming a z-score of 4.5 or higher corresponds to p<0.0001.How we recomputed it: pZ(4.5)
- lowinternal contradictionThe abstract states 'Estimated 36-month overall survival rate was 83.3% with Tec-Dara and 65.0% with DPd/DVd (P<0.0001)' but the results section says 'The overall survival curves crossed around 10 months of follow-up, primarily due to early infectious deaths in the Tec-Dara group.' This crossing may complicate the interpretation of the overall survival benefit, but the RMST analysis supports the benefit.
Estimated 36-month overall survival rate was 83.3% with Tec-Dara and 65.0% with DPd/DVd (P<0.0001). ... The overall survival curves crossed around 10 months of follow-up, primarily due to early infectious deaths in the Tec-Dara group.
Abstractreviewer’s wording
Overstated conclusions
1 finding · worst lowConclusions 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 only partially backed by the presented evidenceAssessed
5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.
- partialReviewers 1, 2Tec-Dara may address the need for a highly effective regimen and community accessibility.The claim is partially supported by the efficacy and subcutaneous administration, but community accessibility is not directly demonstrated in this trial.Evidence: Subcutaneous administration and step-up dosing, but no real-world data in this study.
“Tec-Dara is a synergistic immunotherapy combination that utilizes subcutaneous administration, step-up dosing, and the well-established daratumumab dosing schedule. With the significant progression-free and overall survival benefit, and low rates of grade 2 cytokine release syndrome, Tec-Dara may address the need for a highly effective regimen and community accessibility.”
Discussion ¶3Find in source - supportedReviewers 1, 2Tec-Dara significantly improved progression-free survival compared to DPd/DVd.The claim is supported by the primary endpoint analysis with a hazard ratio of 0.17 and p<0.0001.Evidence: 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).”
AbstractFind in source - supportedReviewers 1, 2Tec-Dara significantly improved overall survival compared to DPd/DVd.The claim is supported by the stratified log-rank test (P<0.0001) and RMST analysis, despite early crossing of survival curves.Evidence: P<0.0001, RMST difference 2.15 months (95% CI 0.54-3.77)
“Estimated 36-month overall survival rate was 83.3% with Tec-Dara and 65.0% with DPd/DVd (P<0.0001).”
AbstractFind in source - supportedReviewers 1, 2Tec-Dara significantly improved response rates and MRD negativity.The claim is supported by significantly higher rates of ≥CR, overall response, and MRD negativity with p<0.0001.Evidence: ≥CR 81.8% vs 32.1%, ORR 89.0% vs 75.3%, MRD negativity 58.4% vs 17.1%, 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).”
AbstractFind in source - supportedReviewers 1, 2Tec-Dara has a manageable safety profile with high frequency of adverse events.The claim is supported by detailed safety data, including grade 3/4 events and deaths, but the high frequency of adverse events is acknowledged.Evidence: Grade 3/4 AEs 95.1% vs 96.6%, deaths due to TEAEs 7.1% vs 5.9%
“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.”
AbstractFind in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- ADEQUATESurrogate endpointThe primary endpoint is progression-free survival (PFS), a hard clinical outcome, and the paper also reports overall survival (OS) as a key secondary endpoint. Although PFS is a surrogate for OS in some contexts, here it is a clinically meaningful endpoint in oncology, and the paper also demonstrates a significant OS benefit. The efficacy claim is primarily based on PFS and OS, which are hard clinical outcomes, not a biomarker or mechanistic proxy.
“The primary endpoint was progression-free survival by independent review committee. ... Tec-Dara demonstrated a statistically significant improvement in progression-free survival and overall survival over standard-of-care DPd/DVd”
- ADEQUATEEffect sizeThe effect size is large and clinically meaningful: HR for PFS is 0.17 (95% CI 0.12–0.23), with 36-month PFS rates of 83.4% vs 29.7%. OS also significantly improved (36-month OS 83.3% vs 65.0%, P<0.0001). These are substantial differences anchored to clinical outcomes, not small fractions or below MCID.
“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). ... Estimated 36-month overall survival rate was 83.3% with Tec-Dara and 65.0% with DPd/DVd (P<0.0001).”
Data authenticity concerns
1 finding · worst lowAn 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).
- lowotherThe paper reports a very large PFS benefit (HR 0.17) which is unusually large for a cancer trial, but it is plausible given the mechanism and the control arm performance.
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)
Resultsreviewer’s wording
Reporting gaps
1 finding · worst mediumRequired 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/code availability incompleteAssessed
The introduction cites prior studies (MajesTEC-1, APOLLO, CASTOR, CARTITUDE-4) and explains the synergistic mechanism of teclistamab and daratumumab. The rationale for the study is clearly linked to the need for off-the-shelf, effective regimens in RRMM. Limitations of prior research are implicitly addressed by the design (e.g., comparing to standard of care).
“Teclistamab, a bispecific antibody targeting CD3×BCMA, demonstrated deep and durable responses in heavily pretreated RRMM in the phase 1/2 MajesTEC-1 study.”
“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.”
“Teclistamab, a bispecific antibody targeting CD3×BCMA, demonstrated deep and durable responses in heavily pretreated RRMM in the phase 1/2 MajesTEC-1 study.”
“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.”
Randomization method is described (1:1, stratified). The unit is patient. Blinding is not used (open-label), but the primary endpoint is assessed by a blinded IRC, which is a standard approach. Power analysis is reported (90% power, 560 patients, 335 events). Inclusion/exclusion criteria are specified. Outlier handling is addressed via pre-specified analysis populations (ITT, safety). Controls are the standard-of-care comparator arm. Independent replication is not applicable for a single pivotal trial.
“Patients were randomly assigned 1:1 to receive Tec-Dara or investigator’s choice of standard-of-care regimens of DPd/DVd. Patients were stratified by investigator’s choice of DPd/DVd, International Staging System (ISS) disease stage (I vs. II vs. III), prior anti-CD38 mAb exposure, and number of prior lines (1 vs. 2 or 3).”
“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.”
“Patients were randomly assigned 1:1 to receive Tec-Dara or investigator’s choice of standard-of-care regimens of DPd/DVd. Patients were stratified by investigator’s choice of DPd/DVd, International Staging System (ISS) disease stage (I vs. II vs. III), prior anti-CD38 mAb exposure, and number of prior lines (1 vs. 2 or 3).”
“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.”
“Response and disease progression were assessed by a blinded IRC per IMWG criteria.”
Sex is reported (male sex percentages). Age and health status (ECOG) are reported. Demographics include race and ethnicity. Species/strain and housing conditions are not applicable for a human trial. The study includes both sexes, so sex_justified is not applicable.
“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)”
“Race, no. (%) | | White | 190 (65.3) | 194 (65.5) | 384 (65.4) | | Asian | 68 (23.4) | 63 (21.3) | 131 (22.3)”
“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)”
“Race, no. (%) | | White | 190 (65.3) | 194 (65.5) | 384 (65.4)”
“International Staging System stage, no. (%) | | I | 182 (62.5) | 185 (62.5) | 367 (62.5)”
The paper states that local independent ethics committees and institutional review boards approved the protocol, all patients provided written informed consent, and the study was conducted in accordance with the Declaration of Helsinki and ICH-GCP. This satisfies all applicable criteria.
“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.”
Teclistamab and daratumumab are named with dosing regimens. The MRD assay is identified as clonoSEQ from Adaptive Biotechnologies. No antibodies, cell lines, or mycoplasma testing are applicable. Statistical software is not named, which is a minor omission but does not affect the overall rating.
“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”
“MRD was assessed in bone marrow aspirates by next-generation sequencing (NGS; clonoSEQ; Adaptive Biotechnologies)”
“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”
“MRD was assessed in bone marrow aspirates by next-generation sequencing (NGS; clonoSEQ; Adaptive Biotechnologies)”
Tests are named (stratified log-rank, Cox, CMH). Assumptions are addressed (proportional hazards, RMST). Exact p-values are reported (e.g., P<0.0001). Effect sizes with CIs are provided (HR, RR). Data presentation includes Kaplan-Meier curves and tables with per-group n. Mathematical plausibility checks: Table 1 percentages sum correctly (e.g., race percentages sum to 100). No arithmetic errors detected.
“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)”
“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)”
No data availability statement is present. The trial registration number is provided, but no repository deposit or accession numbers are given. Code sharing is not applicable. The absence of a data availability statement is a reporting gap.
“Full eligibility criteria are provided in the protocol, available at NEJM.org (https://www.nejm.org/)”
Methods are comprehensive. Trial registration is provided (NCT05083169). Limitations are discussed (e.g., open-label, early infectious deaths). Conclusions are proportional to the data. Funding and COI are disclosed. Reporting guideline is not explicitly mentioned, but the paper is structured per CONSORT.
“ClinicalTrials.gov (http://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.”
“This study and medical writing assistance were funded by Johnson & Johnson.”
“ClinicalTrials.gov (http://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.”
“This study and medical writing assistance were funded by Johnson & Johnson.”
Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.
Broken references and links
None foundReferences 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 DOIReal-world assessment of treatment patterns and outcomes in patients with lenalidomide-refractory relapsed/refractory multiple myeloma from the Optum databaseNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOITECVAYLI ® (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 DOILong-term follow-up from the phase 1/2 MajesTEC-1 trial of teclistamab in patients with relapsed/refractory multiple myelomaNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIDARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) [package insert]No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIDARZALEX ® (daratumumab) injection, for intravenous use [package insert]No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIDosing 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 DOICommon Terminology Criteria for Adverse Events (CTCAE), Version 5.0No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIMagnetisMM-5: An open-label, multicenter, randomized phase 3 study of elranatamab as monotherapy and in combination with daratumumab in patients with relapsed/refractory multiple myelomaNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIPB2133: 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 DOIMonumenTAL-3: Phase 3 trial of talquetamab + daratumumab ± pomalidomide versus daratumumab + pomalidomide + dexamethasone in relapsed/refractory multiple myeloma following ≥1 prior line of therapyNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIEfficacy and safety of teclistamab in relapsed refractory multiple myeloma: long-term follow-up from a real world multi-institutional cohortNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIRisk of infections in multiple myeloma patients treated with bispecific antibodiesNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIDosing patterns and early safety and effectiveness outcomes in patients with multiple myeloma treated with teclistamab in the community settingNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 of 2 data/code links checked; 1 live; 1 not probed.
- datahttps://clinicaltrials.gov/ct2/show/NCT05083169LIVEHTTP 200Resolves, but the content could not be matched to the paper.
- datahttps://www.nejm.org/UNVERIFIEDHTTP 403Liveness indeterminate — content not checked.
Copyediting
5 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 5 minor suggestions below.
5 copyedit issues flagged: mostly consistency, clarity, typo.
- MINORconsistencyAbstract, Results“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).”→ Ensure consistent use of 'P' vs 'p' for p-values throughout the manuscript.The abstract uses 'P<0.0001' while the results section uses 'P<0.0001' as well, but other parts may use lowercase. Consistency is recommended.
- MINORclarityMethods, Study treatments“Subcutaneous daratumumab was dosed per the approved dosing schedule ().”→ Provide the specific dosing schedule or reference to the package insert.The reference to the approved dosing schedule is vague; consider adding a citation or appendix.
- MINORtypoDiscussion, paragraph 4“Progression-free survival benefit with Tec-Dara was observed despite DPd/DVd (median progression-free survival 18.1 months) outperforming expectations per APOLLO (DPd, 12.4 months), CASTOR (DVd, 16.7 months), and CARTITUDE-4 (DPd/PVd, 11.8 months) studies.”→ Consider rephrasing for clarity: '...despite DPd/DVd (median PFS 18.1 months) outperforming expectations from the APOLLO, CASTOR, and CARTITUDE-4 studies.'The sentence is grammatically correct but could be clearer.
- MINORclarityMethods, Study treatments“The teclistamab dosing schedule aligns with the approved daratumumab schedule to increase dosing convenience.”→ Consider rephrasing for clarity: 'The teclistamab dosing schedule was aligned with the approved daratumumab schedule to enhance dosing convenience.'Minor wording improvement.
- MINORconsistencyResults, Safety“Cytokine release syndrome occurred in 60.1% of Tec-Dara patients, all of which were grade 1 (44.2%) or grade 2 (15.9%).”→ Verify that the percentages sum correctly: 44.2% + 15.9% = 60.1%.The percentages appear to sum correctly, but it's worth double-checking.
The published work is robust and well-reported; an informed reader should weigh the minor reporting gaps (missing data availability statement, unnamed statistical software) and the open-label design, which is mitigated by blinded IRC assessment. No erratum is warranted based on the identified issues.
- 1.HIGHdata codeAdd a data availability statement in the Methods or a dedicated section, specifying how de-identified patient-level data can be accessed (e.g., via a data-sharing platform or on request to the sponsor with a data access committee).The paper currently lacks any data availability statement, which is a reporting gap that readers and journals expect.
- 2.HIGHstatisticsIdentify the statistical software used (e.g., SAS version, R version) in the Statistical analysis section.Naming the software enhances reproducibility and is a standard expectation for clinical trial reports.
- 3.MEDIUMreportingExplicitly mention adherence to CONSORT reporting guidelines in the Methods or a separate section, and consider submitting the CONSORT checklist as supplementary material.Explicit guideline adherence improves transparency and is often required by journals.
- 4.MEDIUMdata codeProvide a link to the full study protocol and statistical analysis plan in the data availability statement.Making the protocol and SAP available supports reproducibility and reader confidence.
- 5.MEDIUMreportingIn the Discussion, explicitly acknowledge the open-label design as a potential source of bias and how it was mitigated (e.g., blinded IRC).Addressing the lack of blinding directly strengthens the interpretation of the results.
- 6.MEDIUMstatisticsClarify the handling of missing data for the MRD analysis set, as the NGS analysis set excludes patients from China; describe the imputation or analysis methods for missing MRD assessments.Transparent missing-data handling is essential for the validity of the MRD endpoint.
- 7.MEDIUMreportingClarify the role of the sponsor in data analysis and manuscript preparation, as the current statement is brief.Full disclosure of sponsor involvement is important for assessing potential bias.
- 8.LOWcopyeditEnsure consistent use of 'P' vs 'p' for p-values throughout the manuscript.Consistency in statistical notation improves professionalism and readability.
- 9.LOWcopyeditProvide the specific dosing schedule for subcutaneous daratumumab or reference the package insert in the Methods, Study treatments section.The current vague reference to 'approved dosing schedule' is unclear and should be specified.
- 10.LOWcopyeditRephrase the sentence in the Discussion about DPd/DVd outperforming expectations for clarity.The current sentence is grammatically correct but could be clearer for readers.
- 11.LOWcopyeditRephrase the sentence about teclistamab dosing schedule alignment for clarity.Minor wording improvement enhances readability.
- 12.LOWcopyeditVerify that the percentages for cytokine release syndrome sum correctly (44.2% + 15.9% = 60.1%).Double-checking arithmetic prevents potential errors in reported safety data.
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.”
- 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.
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.