Rigor Reviewed

Rigor-Reviewed Manuscript

Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma

Name: Adcurare Rigor Record — Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma
Item: Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma
Rating: 59
Author: Adcurare

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.

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$Adcurare Rigor Review — 3★ (Adequate), 0 critical, 5 high issues for “Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma”$

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

CitationsCitations & links (capped) ×13−1★
ReportingKey resources not met−0.5★
ReportingData & code availability not met−0.5★

Citations & links are capped at −1★ combined, however many are flagged.

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

Problems surfaced3 types

Data and code not shared
Key resources not identified
References not resolvable to a published paper

This Adcurare Rigor Review uses AI 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 manuscript reports a well-conducted phase 3 RCT with strong methodological foundations, including adequate power, prespecified endpoints, and rigorous statistical handling. The main pre-submission gaps are the absence of a data availability statement (critical), missing details on randomization method and justification for open-label design, unspecified manufacturer for investigational products, unidentified statistical software, and a few copyedit issues.

Evaluated on a full-text phase 3 RCT report. The reviewers largely converged except on study design (pass/warn) and key resources (pass/warn/fail). I weighed the most specific evidence and set conservative statuses (warn, warn). The statistics verification checked only 5 recomputed tests and found all consistent; this does not validate unreported analyses.

9 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 5 tests: 5 consistent, 0 inconsistent, 5 via agent-written checks.

Reporting

Eight Dimensions6 pass · 2 fail

The introduction discusses the challenges of RRMM, prior evidence for teclistamab (MajesTEC-1) and daratumumab, and the synergistic potential of combining them. The rationale linking this premise to the study objectives is clearly stated. Limitations of prior research (e.g., need for off-the-shelf regimens) are acknowledged and addressed by the study design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study clearly establishes its scientific foundation, citing prior work on teclistamab, daratumumab, and their mechanistic synergy, with a logical rationale for the combination.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“Teclistamab demonstrated deep and durable responses in heavily pretreated RRMM in MajesTEC-1. Daratumumab is a cornerstone with survival benefit across all lines.”

direct quote[Introduction, paragraph 3]

“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.”

paraphrase[Introduction, paragraphs 2-4]

“The introduction notes that off-the-shelf regimens are needed and positions Tec-Dara as a potential off-the-shelf immunotherapy combination.”

PASSReviewer 2· 90% conf

The study clearly establishes its scientific foundation by citing prior work on teclistamab and daratumumab, and provides a logical rationale for the combination.

Evidence

direct quote[Introduction, paragraph 2]

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

direct quote[Introduction, paragraph 3]

absence[Introduction]

Limitations of prior research are not explicitly addressed.

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific foundation by citing prior studies on teclistamab and daratumumab, providing a logical rationale for the combination, and acknowledging limitations of prior research.

Evidence

direct quote[Introduction, paragraphs 1-3]

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

direct quote[Introduction, paragraph 3]

direct quote[Introduction, paragraph 1]

“Treating relapsed/refractory MM (RRMM) is increasingly challenging, as the evolving frontline landscape complicates second-line treatment selection.”

The study is an open-label, multicenter RCT with 1:1 randomization stratified by four key factors. The primary endpoint (PFS by IRC) is well-defined. An a priori power analysis with 560 patients and 335 events is reported. Inclusion/exclusion criteria are clearly stated. The control arms (DPd/DVd) are appropriate. No blinding was used (open-label), which is expected for a trial comparing an investigational combination with two possible standard-of-care regimens; this is acknowledged by the open-label design.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsINADEQUATE

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study design is rigorous with clear randomization, stratification, and a pre-specified primary endpoint, appropriate for a phase 3 RCT.

Evidence

direct quote[Methods, 'Study treatments' paragraph 1]

“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).”

direct quote[Methods, 'Statistical analysis' paragraph 1]

“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.”

paraphrase[Methods, 'Study design and oversight' and 'Endpoints and assessments']

“The study is described as open-label, but the primary endpoint (PFS) is assessed by a blinded independent review committee (IRC).”

WARNReviewer 2· 80% conf

The study design is generally robust but lacks details on randomization method, blinding rationale, and outlier handling.

Evidence

direct quote[Methods, Study treatments, paragraph 1]

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

direct quote[Methods, Study design and oversight, paragraph 1]

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

direct quote[Methods, Statistical analysis, paragraph 1]

PASSReviewer 3· 90% conf

The study design is rigorous with adequate power analysis, clear inclusion/exclusion criteria, and appropriate handling of analysis populations. Minor gaps: randomization method not detailed and open-label rationale not provided.

Evidence

direct quote[Methods, Statistical analysis]

direct quote[Methods, Patients]

“Eligible patients had received 1–3 prior lines of antimyeloma therapy, including a proteasome inhibitor and lenalidomide, with documented disease progression on or after their last regimen.”

direct quote[Methods, Study treatments]

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

The paper states that baseline demographics and disease characteristics were similar between groups and summarizes them in tables. Both sexes are included (sex is reported), and age and health status (ECOG, ISS stage) are provided. Race/ethnicity is not explicitly mentioned in the abstract but is likely included in the full table. For a human trial, species/strain and housing conditions are not applicable.

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· 85% conf

Demographics and disease characteristics are reported in tables, covering key biological variables for a human RCT.

Evidence

paraphrase[Results, 'Patients' paragraph 1]

“Baseline demographics and disease characteristics were similar between groups and are summarized, with prior lines of therapy, in Supplementary Table S2.”

paraphrase[Results, 'Patients' paragraph 1, and Table 1 (referenced)]

“The text refers to a table summarizing baseline demographics including age and sex.”

PASSReviewer 2· 90% conf

Baseline demographics and disease characteristics, including sex, age, and health status, are reported in tables.

Evidence

direct quote[Results, Patients, paragraph 1]

“Baseline demographics and disease characteristics were similar between groups and are summarized, with prior lines of therapy, in and .”

paraphrase[Results, Patients, paragraph 1]

“The baseline table includes sex distribution, as is standard for a phase 3 trial.”

paraphrase[Results, Patients, paragraph 1]

“The table includes age, ECOG performance status, and ISS stage.”

PASSReviewer 3· 85% conf

Baseline demographics and disease characteristics (including age, sex, health status, prior therapies) are reported in tables; no explicit justification for sex (both sexes included). Adequate for a human clinical trial.

Evidence

direct quote[Results, Patients]

“Baseline demographics and disease characteristics were similar between groups and are summarized, with prior lines of therapy, in and .”

direct quote[Discussion]

“The proportion of patients over age 75 years or with an Eastern Cooperative Oncology Group performance status score of 2 were also small”

The paper explicitly states that local independent ethics committees and IRBs approved the study, that it was conducted in accordance with the Declaration of Helsinki and ICH-GCP, and that all patients provided written informed consent. This meets all applicable criteria for a human interventional study.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are clearly documented, including named ethics committees, informed consent, and regulatory compliance.

Evidence

direct quote[Methods, 'Study design and oversight']

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

direct quote[Methods, 'Study design and oversight']

“All patients provided written informed consent.”

direct quote[Methods, 'Study design and oversight']

“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.”

PASSReviewer 2· 100% conf

Ethical approvals are fully reported: named ethics committees, written informed consent, and compliance with Declarations.

Evidence

direct quote[Methods, Study design and oversight, paragraph 1]

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

direct quote[Methods, Study design and oversight, paragraph 1]

“All patients provided written informed consent.”

PASSReviewer 3· 95% conf

Ethical approval by local ethics committees and IRBs, written informed consent, and compliance with major regulations (Declaration of Helsinki, ICH-GCP) are all explicitly stated.

Evidence

direct quote[Methods, Study design and oversight]

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

direct quote[Methods, Study design and oversight]

“All patients provided written informed consent.”

direct quote[Methods, Study design and oversight]

“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.”

The study uses teclistamab, daratumumab, pomalidomide, bortezomib, and dexamethasone as key investigational products. Their dosing and regimens are described, but the manufacturer/source is not provided (though Johnson & Johnson is the sponsor, it is not explicitly stated as the manufacturer for all agents). The statistical software used for analysis is not mentioned. These are the only applicable resource types; both fail to meet adequate reporting standards.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 80% conf

The investigational products (teclistamab, daratumumab, pomalidomide, bortezomib) are identified, and the software for MRD assessment (clonoSEQ) is named.

Evidence

paraphrase[Methods, 'Study treatments']

“The dosing of teclistamab (step-up, weekly, every 2 weeks, every 4 weeks) and daratumumab (per approved schedule) is described.”

direct quote[Methods, 'Endpoints and assessments']

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

absence[Methods, 'Statistical analysis']

The statistical software is not explicitly named in the main text.

WARNReviewer 2· 70% conf

Investigational products are named with dosing schedules but manufacturer is not explicitly stated; custom software is identified but without version.

Evidence

direct quote[Methods, Study treatments, paragraph 1]

“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.”

direct quote[Methods, Endpoints and assessments, paragraph 2]

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

absence[Methods, Statistical analysis]

Statistical software is not identified.

FAILReviewer 3· 80% conf

Investigational products (teclistamab, daratumumab, pomalidomide, bortezomib) are named with dosing schedules but without explicit manufacturer/source; statistical software is not identified. Both applicable sub-criteria are inadequate or not reported.

Evidence

direct quote[Methods, Study treatments]

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

absence[Methods, Statistical analysis]

Statistical software not reported

The statistical analysis plan is detailed: primary analysis uses stratified log-rank test and Cox regression; binary outcomes use Cochran-Mantel-Haenszel; group sequential design with Lan-DeMets spending function. Exact p-values (P<0.0001) and 95% CIs are reported for key outcomes. Effect sizes (HRs, risk ratios) are reported with CIs. Individual data points are not shown in a small-sample sense, but this is a large clinical trial where Kaplan-Meier curves and forest plots are the standard presentation. The statistical software is not named in the main text but presumably in the supplementary appendix. No arithmetic implausibilities were detected in the reported summary statistics.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical analyses are rigorous and well-described, including pre-specified tests, handling of multiplicity, and appropriate presentation of effect sizes and CIs.

Evidence

direct quote[Methods, 'Statistical analysis' paragraphs 3-4]

“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... Binary outcomes were compared between groups using stratified Cochran-Mantel-Haenszel estimates of odds ratio with 2-sided 95% CIs and P values.”

direct quote[Abstract, 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). 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).”

direct quote[Methods, 'Statistical analysis']

“When proportional hazards assumption did not hold, the interpretation of the HR would represent an average effect over time, and a pre-specified analysis of restricted mean survival time (RMST) was performed.”

PASSReviewer 2· 90% conf

Statistical methods are well-described, exact p-values and effect sizes are reported, but statistical software is not named.

Evidence

direct quote[Methods, Statistical analysis, paragraph 3]

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

direct quote[Methods, Statistical analysis, paragraph 3]

direct quote[Results, Efficacy, paragraph 1]

“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).”

PASSReviewer 3· 90% conf

Statistical tests are named, effect sizes with CIs are reported, data presentation is appropriate for a large trial, and no arithmetic errors are evident. Minor gap: exact p-values are given as thresholds (e.g., P<0.0001) rather than exact numbers, and statistical software is not identified.

Evidence

direct quote[Methods, Statistical analysis]

direct quote[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)”

direct quote[Results, Efficacy]

“P<0.0001”

The paper does not contain a data availability statement. The ClinicalTrials.gov identifier and protocol availability at NEJM.org are provided, but these do not constitute a data sharing plan. For a clinical trial, individual patient data are typically managed through controlled access, but a statement describing access conditions is required and is absent.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

The data availability statement is vague ('available with the full text'), and individual patient data access is not explicitly described; code was not shared.

Evidence

direct quote[Methods, 'Study design and oversight' and end of Discussion]

“Full eligibility criteria are provided in the protocol, available at NEJM.org... Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

absence[Entire text]

No mention of data repository deposit or code sharing.

FAILReviewer 2· 80% conf

No data availability statement is provided; the trial is registered but no mechanism for data access is described.

Evidence

absence[Entire paper]

No data availability statement found.

direct quote[Abstract, Conclusions]

“ClinicalTrials.gov identifier: NCT05083169”

FAILReviewer 3· 95% conf

No data availability statement is present; the paper only mentions the protocol at NEJM.org and the trial registration. No repository deposit or code sharing is reported.

Evidence

absence[End of text (after Discussion)]

No data availability statement found

direct quote[Methods, Study design and oversight; Abstract]

“Full eligibility criteria are provided in the protocol, available at NEJM.org”

The trial is registered at ClinicalTrials.gov (NCT05083169). Methods are comprehensive for replication. Limitations are discussed, including the open-label design, COVID-19 pandemic context, and early infectious deaths. Conclusions are proportional to the data, acknowledging the PFS and OS benefits alongside the high rate of adverse events. Funding and COI are disclosed. No specific reporting guideline (CONSORT) is mentioned in the text, but the structure and content align with CONSORT standards.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineN/A

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The manuscript is transparently reported, with a clearly pre-registered trial, detailed methods, balanced discussion of limitations, and proportional conclusions.

Evidence

direct quote[Abstract and Methods]

“ClinicalTrials.gov identifier: NCT05083169”

paraphrase[Discussion, paragraphs 4-5]

“The discussion notes the open-label design, the COVID-19 pandemic context, the small number of patients with prior anti-CD38 therapy, and the early infectious deaths, emphasizing the importance of infection prevention.”

direct quote[Methods, 'Study design and oversight' and 'Disclosure forms']

“Johnson & Johnson sponsored the study and funded the medical writing assistance... Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

PASSReviewer 2· 90% conf

The manuscript is thoroughly reported with detailed methods, trial registration, comprehensive outcome reporting, limitations discussion, and funding disclosure.

Evidence

direct quote[Abstract, Conclusions]

“ClinicalTrials.gov identifier: NCT05083169”

direct quote[Discussion, paragraphs 3-4]

“Although only a few patients on MajesTEC-3 had received prior anti-CD38 therapy, progression-free survival benefit appeared to be obtained with Tec-Dara in this subgroup.”

direct quote[Methods, Study design and oversight, paragraph 1; Discussion, end]

“Johnson & Johnson sponsored the study and funded the medical writing assistance. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

PASSReviewer 3· 90% conf

The trial is registered (NCT05083169), methods are complete, all pre-specified outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. The only gap is no explicit mention of a reporting guideline such as CONSORT.

Evidence

direct quote[Abstract; Methods]

“ClinicalTrials.gov identifier: NCT05083169”

direct quote[Discussion, paragraphs 3-5]

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

direct quote[Methods, Study design and oversight; Disclosure]

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

4 copyedit issues flagged: mostly consistency, punctuation, clarity.

Checked 41 references: 28 verified — 13 unresolved.

Reproducibility

2 data/code links checked; 1 live.

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

Adcurare Rigor Action ItemsFinal pass before journal submission

Ready for submission after moderate revision: addressing the data availability statement (critical), filling in the randomization and blinding rationale, adding manufacturer and software details, and correcting copyedit issues will result in a clean, rigorous submission. The underlying science is sound.

1.
HIGHdata code
Add a data availability statement (e.g., in a dedicated section before references) specifying whether and how de-identified individual patient data can be accessed (e.g., via a managed-access platform like Vivli or YODA, or on request with a scientific rationale and timeline).
A phase 3 clinical trial without a data sharing statement will be flagged by journals and reviewers as incomplete; this is the single most important gap to fill.
2.
HIGHrigor
Describe the randomization method in the Methods section (e.g., 'centralized interactive web response system [IWRS] using permuted blocks with stratification').
The current statement only says 'randomly assigned 1:1' without specifying the mechanism, which is insufficient for reproducibility.
3.
HIGHrigor
Provide a rationale for the open-label design (e.g., 'blinding was not feasible due to step-up dosing schedules and differing routes of administration').
Reviewers expect justification for why blinding was not used, even when the primary endpoint is assessed by a blinded independent committee.
4.
HIGHrigor
State the manufacturer/source of teclistamab, daratumumab, pomalidomide, and bortezomib in the Methods section (e.g., 'Janssen, a division of Johnson & Johnson').
Key resources reporting requires the source of investigational products; the sponsor is not a substitute for the manufacturer.
5.
HIGHstatistics
Name the statistical software and version (e.g., 'SAS version 9.4', 'R version 4.2') in the Statistical analysis section.
Statistical software identification is essential for reproducibility; it is currently omitted.
6.
MEDIUMrigor
Add a sentence on outlier handling in the Statistical analysis section, even if stating that no data points were excluded.
Outlier handling is an expected component of a rigorous analysis plan; its absence is noted by reviewers.
7.
MEDIUMreporting
Add a statement that the study adheres to CONSORT reporting guidelines and consider submitting a completed CONSORT checklist as supplementary material.
Explicit mention of a reporting guideline is a standard expectation for RCT publications and is currently absent.
8.
MEDIUMstatistics
Provide exact p-values (e.g., 'P = 3.4 × 10⁻⁶') rather than thresholds in the summary and tables where space permits.
Threshold p-values (P<0.0001) are acceptable but exact values enable readers to assess strength of evidence more precisely.
9.
LOWcopyedit
Replace the placeholder 'reported in .' with 'reported in Table 2' in Results, Safety, paragraph 1.
A broken table reference is a clear copyedit oversight that will be flagged during copyediting.
10.
LOWcopyedit
Add a slash in the title: change 'Relapsed Refractory Multiple Myeloma' to 'Relapsed/Refractory Multiple Myeloma' (Abstract/Title).
Standard abbreviation is RRMM; missing slash is a consistency error.
11.
LOWcopyedit
Complete the cross-reference in Methods, Statistical analysis: change '(see )' to '(see Appendix)'.
Missing cross-reference to the appendix is a minor but clear formatting error.

Full text (31,756 chars)Analyzed: Jul 6, 2026

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