Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma

Phase 3

Completed

Conditions: bone marrow cancer
Morbus Kahler
10035227

Registration Number: NL-OMON55578

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4

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

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Assessment of tumor response and disease progression will be conducted in<br /><br>accordance with the IMWG response criteria. Disease evaluations will include<br /><br>measurements of myeloma proteins, bone marrow examinations, skeletal surveys,<br /><br>assessment of extramedullary plasmacytomas, and measurements of serum calcium<br /><br>corrected for albumin. Survival status and subsequent anticancer treatment data<br /><br>will also be collected.</p><br>

Secondary Outcome Measures