A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone with Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

• Conditions: Multiple myeloma; MedDRA version: 16.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-005525-23-ES
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-01
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Inclusion Criteria:
- Must have documented multiple myeloma and measurable disease
- Must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen
- 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
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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

Exclusion Criteria:
- Has received any of the following therapies: daratumumab or other anti-CD38 therapies
- Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment
- Disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment
- Has received autologous stem cell transplantation within 12 weeks before the date of randomization, or previously received an allogenic stem cell transplant (regardless of timing), or planning to undergo a stem cell transplant prior to progression of disease
- History of malignancy (other than multiple myeloma) within 3 years before the date of randomization

Study & Design

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