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An Organotypic High Throughput System for Characterization of Drug Sensitivity of Primary Multiple Myeloma Cells
Published on: July 15, 2015
Reporting of Postprotocol Therapies and Attrition in Multiple Myeloma Randomized Clinical Trials: A Systematic Review
Ghulam Rehman Mohyuddin1, Kelly Koehn1, Al-Ola Abdallah2
1Department of Hematological Malignancies and Cellular Therapeutics, Kansas University Medical Center, Kansas City.
Importance:
A thorough understanding of the optimal role and sequence of agents for treatment of multiple myeloma (MM) requires knowledge of the use and rate of postprotocol therapies in randomized clinical trials (RCTs).
Objectives:
To examine the proportion of MM RCTs that reported postprotocol therapies and, among those, the percentage of patients who received no further therapy and how treatments differed between the control and intervention arms.
Evidence Review:
The reporting of postprotocol therapies was systematically assessed in published MM RCTs using 3 databases (PubMed, Embase, and Cochrane Registry of Controlled Trials) for MM RCTs from January 1, 2005, to December 30, 2019. All MM RCTs were included, and all other studies, such as editorials, nonrandomized studies, and review articles, were excluded.
Findings:
A total of 103 RCTs were identified (47 251 patients); of these, 45 (43.7%) reported subsequent treatments in that publication or in any subsequent publication. Trials funded by pharmaceutical companies (26 of 47 [55.3%]) were more likely to report subsequent treatments than cooperative group studies (19 of 56 [33.9%]) (χ21,103 = 4.8; P = .03). Differences were found in the treatments received between the intervention and control arms of RCTs. When data were reported, 5150 of 9351 patients (54.9%) in RCTs of newly diagnosed MM and 2197 of 4501 patients (48.8%) in RCTs of relapsed/refractory MM received any subsequent therapy.
Conclusions And Relevance:
Postprotocol therapies in MM RCTs are often not reported and, when they are, many patients receive no further therapy. Reporting guidelines for postprotocol therapies are needed.
Insights
Many multiple myeloma (MM) clinical trials do not report post-treatment therapies. When reported, a significant portion of patients receive no further treatment, highlighting a need for better reporting guidelines in MM research.
Area of Science:
- Hematology
- Clinical Trials
- Oncology
Background:
- Optimal treatment sequencing for multiple myeloma (MM) necessitates understanding post-protocol therapies in randomized clinical trials (RCTs).
- Knowledge gaps exist regarding the reporting and utilization of subsequent treatments in MM clinical research.
Purpose of the Study:
- To assess the reporting rates of post-protocol therapies in MM RCTs.
- To determine the proportion of patients receiving no further therapy after trial completion.
- To compare subsequent treatment differences between control and intervention arms in MM RCTs.
Main Methods:
- Systematic review of MM RCTs published between January 1, 2005, and December 30, 2019.
- Searches conducted across PubMed, Embase, and Cochrane Registry of Controlled Trials.
- Inclusion of all MM RCTs; exclusion of non-randomized studies and reviews.
Main Results:
- Of 103 identified MM RCTs (47,251 patients), only 43.7% reported post-protocol therapies.
- Pharmaceutical company-funded trials were more likely to report subsequent treatments (55.3%) than cooperative group studies (33.9%).
- Subsequent therapy was received by 54.9% of newly diagnosed MM patients and 48.8% of relapsed/refractory MM patients when data were reported.
Conclusions:
- Post-protocol therapy reporting in multiple myeloma RCTs is inconsistent and often inadequate.
- A substantial percentage of patients in MM RCTs do not receive further treatment after trial conclusion.
- Development of standardized reporting guidelines for post-protocol therapies in MM clinical trials is crucial.
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