Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants with Relapsed or Refractory Multiple Myeloma

Phase 1

• Conditions: Multiple myeloma; MedDRA version: 19.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000255-85-HU
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-12
• Study Completion: 2021-06-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 498

Inclusion Criteria

-Must have had documented multiple myeloma
-Must have received at least 1 prior line of therapy for multiple myeloma
­Must have had documented evidence of progressive disease as defined based on Investigator’s determination of response of International Myeloma Working Group (IMWG) criteria on or after their last regimen
­Must have an Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
­Must have 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 in the past

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 192
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 288

Exclusion Criteria

-Has received daratumumab or other anti­CD38 therapies previously
­Is refractory to VELCADE or another PI, like ixazomib and carfilzomib (had progression of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy or another PI therapy, like ixazomib and carfilzomib
­Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
­Has received anti­myeloma treatment within 2 weeks or 5 pharmacokinetic half­lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day [mg/day] for a maximum of 4 days) before treatment. A list of anti­myeloma treatments with the corresponding pharmacokinetic half­lives is provided in the Site Investigational Product Procedures Manual (IPPM).
­Has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization
­Has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified