NCT05519085

A Study to Evaluate CC-92480, Bortezomib and Dexamethasone (480Vd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (SUCCESSOR-1)


Sponsor: Bristol-Myers Squibb

Purpose of this study?


The purpose of this study is to compare the efficacy and safety of CC-92480, bortezomib and dexamethasone (480Vd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Approximately 760 patients will be enrolled in the study.


Key Inclusion Criteria:

 

  • Participant has documented diagnosis of MM and measurable disease, defined as any of the following:
  • M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or
  • M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP)
  • For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
  • Participants received 1 to 3 prior lines of antimyeloma therapy.
  • Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.

Other protocol-defined criteria apply.


Key Exclusion Criteria:

 

  • Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor.
  • For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
  • Participant has had prior treatment with CC-92480 or pomalidomide.

Other protocol-defined criteria apply.


Primary Outcome Measures:

 

  1. Progression-free Survival (PFS)


Secondary Outcome Measures:

 

1.        Recommended CC- 92480 dose (Stage 1 only)

2.        Overall Survival (OS)

3.        Overall Response Rate (ORR)

4.        Percentage of participants with Complete Response Rate (CRR) or

5.        Percentage of participants with Very Good Partial Response Rate (VGPRR) or better

6.        Time to Response (TTR)

7.        Duration of Response (DOR)

8.        Time to Progression (TTP)

9.        Time to Next Treatment (TTNT)

10.        Progression-free Survival 2 (PFS-2)

11.        Minimal Residual Disease (MRD) negativity rate

12.        Number of participants with Adverse Events (AEs)

13.        Mean Change from baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Health Related Quality of Life Scores. The EORTC QLQ-C30 is the most commonly used quality of life instrument in oncology trials. The QLQ-C30 consists of 30 questions incorporated into the physical, role, cognitive, emotional, and social domains. It will also include an assessment of symptoms such as fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Additionally, a single global Quality of Life (QoL)/global health status score will be collected. (Stage 2 only).

14.        Mean change from baseline in the European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20). The EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. (Stage 2 only).


Study Locations in Europe: Austria, Belgium, Finland, France, Germany, Greece, Ireland, Israel, Italy, Poland, Portugal, Romania, Spain, Turkey, United Kingdom.

 

Estimated Study Completion Date: November 2025

 

Further information on clinicaltrial.gov - trial number NCT05519085




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