A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to compare the efficacy of daratumumab when combined with Velcade (bortezomib) and dexamethasone (DVd) to that of Velcade and dexamethasone (Vd), in terms of progression free survival (PFS) in Chinese participants with relapsed or refractory multiple myeloma (MM).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; BB 1101; Bortezomib; Daratumumab; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Documented multiple myeloma (MM) as defined by the criteria: monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) at some point in the participant's disease course or presence of a biopsy-proven plasmacytoma

• Received at least 1 prior line of therapy for MM

• Documented evidence of progressive disease (PD) based on investigator's determination of response as defined by the International Myeloma Working Group (IMWG) criteria on or after their last regimen

• Achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2

Exclusion Criteria:

• Received daratumumab or other anti-CD38 therapies

• Refractory to Velcade, or another proteasome inhibitor (PI), like ixazomib and carfilzomib (ie, participant had progression of disease while receiving Velcade therapy or within 60 days of ending Velcade therapy, or another PI, like ixazomib and carfilzomib, etc)

• Intolerant to Velcade (that is [ie], discontinued due to any adverse event while on Velcade treatment)

• Planning to undergo a stem cell transplant prior to progression of disease on this study, that is ie, these participants should not be enrolled in order to reduce disease burden prior to transplant

• History of malignancy (other than MM) within 3 years before the date of randomization