Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1
Open accessAbstract
It is essential that there be consistency in the conduct, analysis, and reporting of clinical trial results in myeloma. The goal of the International Myeloma Workshop Consensus Panel 1 was to develop a set of guidelines for the uniform reporting of clinical trial results in myeloma. This paper provides a summary of the current response criteria in myeloma, detailed definitions for patient populations, lines of therapy, and specific endpoints. We propose that future clinical trials in myeloma follow the guidelines for reporting results proposed in this manuscript.
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Progression was determined with a validated computer algorithm that combined laboratory results and applicable imaging and generated the outcome according to IMWG criteria; this algorithm previously showed very strong concordance with independent reviews in a phase 2 study.
“The primary end point was progression-free survival, with progression determined with the use of a validated computer algorithm that combined laboratory results (e.g., M-protein level) and applicable imaging and generated the outcome according to IMWG criteria (see the Supplementary Appendix).20,21 This algorithm previously showed very strong concordance with independent reviews in a phase 2 study”
From Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. (2016) · cites this paper as [21]
Split into 2 atoms — 0 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredThe primary end point of the phase 2 study was overall response rate, defined as partial response or better according to IMWG criteria, as assessed by an independent review committee.
“The primary end point of the phase 2 study was the overall response rate, which was defined as a partial response or better according to the criteria of the International Myeloma Working Group, as assessed by an independent review committee”
From Teclistamab in Relapsed or Refractory Multiple Myeloma (2022) · cites this paper as [10]
The Response criteria section recommends IMWG criteria for clinical trials and endorses the IMWG definition of partial response; the Minimal response section also distinguishes partial response or better from minimal response. The paper does not establish that overall response rate was the primary endpoint of the particular phase 2 study or that an independent review committee assessed it (pages not provided). (LLM, conf=0.87)
Experimental — accuracy not yet measuredResponse was assessed according to the Uniform Criteria Consensus recommendations of the International Myeloma Working Group.
“Response was assessed according to the Uniform Criteria Consensus recommendations of the International Myeloma Working Group.20,21”
From Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. (2016) · cites this paper as [21]
Treatment responses and disease progression were determined according to the International Myeloma Working Group criteria with the use of a validated computer algorithm.
“Treatment responses and disease progression were determined according to the International Myeloma Working Group criteria 16 with the use of a validated computer algorithm. 19”
From Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. (2023) · cites this paper as [16]
Although anti-BCMA therapies are approved and have shown clinical benefit for relapsed or refractory multiple myeloma, relapses continue, indicating a need for novel therapies to expand treatment options.
“Although anti-BCMA therapies are approved and have shown clinical benefit for patients with relapsed or refractory multiple myeloma,4–7 relapses continue; thus, there is a need for novel therapies to expand treatment options.”
From Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. (2025) · cites this paper as [6]
The citation follows the claim that approved anti-BCMA therapies benefit patients with relapsed or refractory multiple myeloma. The Refractory myeloma and Relapsed myeloma sections define those disease states, but our copy does not address anti-BCMA therapy, its approval, or its clinical benefit (searched: anti-BCMA, BCMA, novel therapies). (LLM, conf=0.77)
Experimental — accuracy not yet measured
Disease evaluations were performed by the investigators in accordance with the 2011 IMWG response criteria.
“Disease evaluations were performed by the investigators in accordance with the 2011 IMWG response criteria. 22”
From Talquetamab, a T-Cell–Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma (2022) · cites this paper as [22]
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Cites
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- [12]12. Durie BGM, Rajkumar SV. Assessing response rates in clinical trials of treatment for relapsed or refractory multiple myeloma. Leukemia. 2007; 21(4):821.
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Self-citation
- Authors
- Rajkumar, S. V., Harousseau, J.-L., Durie, B., Anderson, K. C., Dimopoulos, M., Kyle, R., Blade, J., Richardson, P., Orlowski, R., Siegel, D., Jagannath, S., Facon, T., Avet-Loiseau, H., Lonial, S., Palumbo, A., Zonder, J., Ludwig, H., Vesole, D., Sezer, O., Munshi, N. C., San Miguel, J., & 1, O. B. O. T. I. M. W. C. P.
- Affiliations
- Mayo Clinic (US)
- Université de Nantes (FR)
- Cedars-Sinai Medical Center (US)
- Dana-Farber Cancer Institute (US)
- National and Kapodistrian University of Athens (GR)
- Hospital Clinic in Barcelona, Barcelona, Spain;
- The University of Texas MD Anderson Cancer Center (US)
- Hackensack University Medical Center (US)
- Mount Sinai Hospital (US)
- Université de Lille (FR)
- Universitaire de Nantes, Nantes, France;
- Emory University (US)
- University of Turin (IT)
- Wayne State University (US)
- Wilhelminen Hospital (AT)
- University Medical Center Hamburg-Eppendorf (DE)
- VA Boston Healthcare System (US)
- Hospital Universitario, Instituto de Biología Molecular y Celular del Cáncer, Centro de Investigación del Cáncer, Salamanca, Spain
- ORCID
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 2011-05-05
- Volume
- 117
- Issue
- 18
- Pages
- 4691-4695
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- PMC
- PMC3710442
- OpenAlex
- W2003734726
- Cited by
- 1,036
- References
- 17
- Citations by year
- 2026: 23 · 2025: 62 · 2024: 58 · 2023: 71 · 2022: 94 · 2021: 90 · 2020: 94 · 2019: 90 · 2018: 68 · 2017: 90 · 2016: 87 · 2015: 54 · 2014: 49 · 2013: 55 · 2012: 34
- FWCI
- 32.64
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Blood (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- DIGITAL.CSIC (Spanish National Research Council (CSIC)) (submittedVersion)
- Funders
- Amgen
- Bristol-Myers Squibb
- Celgene
- Universidad de Salamanca
- National Cancer Institute (R01CA107476)
- Cilag
- Topics
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- multiple myeloma, clinical trial reporting, reporting guidelines, response criteria, treatment lines, clinical trial endpoints
- MeSH terms
- Clinical Trials as Topic, Humans, Multiple Myeloma, Recurrence, Treatment Outcome, Clinical Trials, Phase III as Topic
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