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Analysis of Common Eligibility Criteria of Randomized Controlled Trials in Newly Diagnosed Multiple Myeloma Patients and Extrapolating Outcomes.

Publication ,  Journal Article
Shah, JJ; Abonour, R; Gasparetto, C; Hardin, JW; Toomey, K; Narang, M; Srinivasan, S; Kitali, A; Zafar, F; Flick, ED; Rifkin, RM
Published in: Clin Lymphoma Myeloma Leuk
September 2017

BACKGROUND: The performance of multiple myeloma (MM) therapies in a general patient population and specific eligibility criteria that might limit enrollment into randomized controlled trials (RCTs) have not been evaluated in depth. This study aimed to determine if improvements seen with MM therapies in RCTs are reflected in the general patient population and to identify eligibility criteria that can be modified to increase enrollment. PATIENTS AND METHODS: The Connect MM Registry is a prospective observational cohort study of patients with newly diagnosed MM (NDMM) in the United States. Using common RCT exclusion criteria collected from 16 published studies, patients in the registry were categorized according to their eligibility for inclusion in RCTs. RESULTS: On the basis of common criteria, 563 of 1406 of registry patients (40.0%) are ineligible for RCTs. Criteria leading to exclusion included M-protein ≤ 1.0 g/dL (25.2%), creatinine > 2.5 mg/dL (13.9%), low absolute neutrophil count (10.0%), and low hemoglobin (9.6%). Significantly more RCT-ineligible versus RCT-eligible patients had hypercalcemia (11.0% vs. 5.5%), elevated creatinine levels (38.9% vs. 6.2%), low hemoglobin levels (59.5% vs. 39.5%), or International Staging System stage III disease (40.1% vs. 22.1%; P < .001 for all comparisons). RCT-ineligible patients had a lower 3-year survival rate than RCT-eligible patients (63% vs. 70%). The incidence of serious adverse events was similar between groups. CONCLUSION: Of patients with NDMM enrolled in the Connect MM Registry, 40% are ineligible for RCTs. This study provides insight into potential modifications of standard eligibility criteria that can lead to improved RCT design and accelerated enrollment.

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Published In

Clin Lymphoma Myeloma Leuk

DOI

EISSN

2152-2669

Publication Date

September 2017

Volume

17

Issue

9

Start / End Page

575 / 583.e2

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Research Design
  • Registries
  • Randomized Controlled Trials as Topic
  • Neoplasm Staging
  • Multiple Myeloma
  • Middle Aged
  • Male
  • Humans
 

Citation

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Shah, J. J., Abonour, R., Gasparetto, C., Hardin, J. W., Toomey, K., Narang, M., … Rifkin, R. M. (2017). Analysis of Common Eligibility Criteria of Randomized Controlled Trials in Newly Diagnosed Multiple Myeloma Patients and Extrapolating Outcomes. Clin Lymphoma Myeloma Leuk, 17(9), 575-583.e2. https://doi.org/10.1016/j.clml.2017.06.013
Shah, Jatin J., Rafat Abonour, Christina Gasparetto, James W. Hardin, Kathleen Toomey, Mohit Narang, Shankar Srinivasan, et al. “Analysis of Common Eligibility Criteria of Randomized Controlled Trials in Newly Diagnosed Multiple Myeloma Patients and Extrapolating Outcomes.Clin Lymphoma Myeloma Leuk 17, no. 9 (September 2017): 575-583.e2. https://doi.org/10.1016/j.clml.2017.06.013.
Shah JJ, Abonour R, Gasparetto C, Hardin JW, Toomey K, Narang M, et al. Analysis of Common Eligibility Criteria of Randomized Controlled Trials in Newly Diagnosed Multiple Myeloma Patients and Extrapolating Outcomes. Clin Lymphoma Myeloma Leuk. 2017 Sep;17(9):575-583.e2.
Shah, Jatin J., et al. “Analysis of Common Eligibility Criteria of Randomized Controlled Trials in Newly Diagnosed Multiple Myeloma Patients and Extrapolating Outcomes.Clin Lymphoma Myeloma Leuk, vol. 17, no. 9, Sept. 2017, pp. 575-583.e2. Pubmed, doi:10.1016/j.clml.2017.06.013.
Shah JJ, Abonour R, Gasparetto C, Hardin JW, Toomey K, Narang M, Srinivasan S, Kitali A, Zafar F, Flick ED, Rifkin RM. Analysis of Common Eligibility Criteria of Randomized Controlled Trials in Newly Diagnosed Multiple Myeloma Patients and Extrapolating Outcomes. Clin Lymphoma Myeloma Leuk. 2017 Sep;17(9):575-583.e2.
Journal cover image

Published In

Clin Lymphoma Myeloma Leuk

DOI

EISSN

2152-2669

Publication Date

September 2017

Volume

17

Issue

9

Start / End Page

575 / 583.e2

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Research Design
  • Registries
  • Randomized Controlled Trials as Topic
  • Neoplasm Staging
  • Multiple Myeloma
  • Middle Aged
  • Male
  • Humans