Randomized Phase 3 Study of Pomalidomide Cyclophosphamide Dexamethasone (PCD) Versus Pomalidomide Dexamethasone (PD) in Relapse or Refractory Myeloma: An Asian Myeloma Network (AMN) Study

Introduction Patients with multiple myeloma (MM) who relapse or are refractory to (RRMM) lenalidomide and bortezomib have survival of less than 1 year. Pomalidomide (pom) is an immunomodulatory drug shown to improve survival in this group of patients 1. Optimal drugs to combine pom with are not know...

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Published in:Blood 2023-11, Vol.142 (Supplement 1), p.1009-1009
Main Authors: Song, Yang, Kim, Jin Seok, Chim, CS, Lee, Je-Jung, Yoon, Sung-Soo, Ng, Soo Chin, Gan, Gin Gin, Handa, Hiroshi, Jen, Wei-Ying, Li, Xinhua, Pokharkar, Yogesh Mahadev, Durie, Brian GM, Chng, Wee-Joo
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Language:English
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Summary:Introduction Patients with multiple myeloma (MM) who relapse or are refractory to (RRMM) lenalidomide and bortezomib have survival of less than 1 year. Pomalidomide (pom) is an immunomodulatory drug shown to improve survival in this group of patients 1. Optimal drugs to combine pom with are not known; patients tend to be triple class refractory by the time they require pom. We aim to compare pom, cyclophosphamide and dexamethasone (PCD) with pom and dexamethasone (PD) in Asian patients with RRMM 2. Methods This was a randomized, two arm, multicentre, multinational, prospective phase 3 study. RRMM patients with prior exposure to proteasome inhibitor (bortezomib, carfilzomib or ixazomib) and lenalidomide were recruited. Other inclusion criteria were: measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, satisfactory organ function (neutrophil count ≥ 1 000/mm 3, platelet ≥ 50 000/mm 3, bilirubin ≤ 1.5 x upper limit of the normal range (ULN), alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN and creatinine clearance ≥ 30ml/min). Patients with plasma cell leukaemia, > 6 lines of treatment or prior exposure to pom were excluded. Patients were randomized in a 1:1 ratio to receive PCD or PD. Dosing schedule was 4-weekly: pom 4mg day 1 - 21, dexamethasone 40mg twice a week and, for patients on PCD, cyclophosphamide 400mg weekly for 3 weeks. Patients received treatment until disease progression, unacceptable toxicity determined by treating physician, consent withdrawal or death. A modified intention-to-treat population was used for analysis, which included all randomized patients receiving at least 1 dose of study drug. Primary endpoint was progression free survival (PFS), defined as time from start of treatment to disease progression or death from any cause. Secondary endpoints were overall response rate (ORR, percentage of patients achieving partial response (PR) or better), overall survival (OS), duration of response (DOR, time from first evidence of PR or better till disease progression or death, whichever occurred first) and safety, assessed by frequency and percentage of adverse events by severity. PFS, OS and DOR were presented using Kaplan-Meier curves. Comparison between 2 arms was performed by Cox proportional hazard model for PFS, OS and DOR, using generalized linear model with binomial distribution for ORR. Results 124 patients were recruited, of whom 122 received at least 1 dose of study drug (62 PCD, 60 P
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2023-184723