A Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) with Bortezomib and Dexamethasone (Vd) in Relapsed or Refractory Multiple Myeloma

Phase 1

• Conditions: Multiple myeloma; MedDRA version: 17.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-01
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

- Must have documented multiple myeloma
- Must have received at least 1 prior line of therapy for multiple myeloma
- Must have documented evidence of progressive disease as defined by the
International Myeloma Working Group 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 or better) to at least 1 prior regimen
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 anti-CD38 therapies previously
- Is refractory to VELCADE (had progression of disease while receiving VELCADE therapy or within 60 days of ending VELCADE therapy
- Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
- Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization
- 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