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Monoclonal Antibodies

Daratumumab + Lenalidomide + Dexamethasone for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Paul Richardson, MD
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with lenalidomide and dexamethasone (Len/Dex)
Have received at least 1 prior line of therapy for multiple myeloma
Must not have
Have previously received an allogenic stem cell transplant
Have received autologous stem cell transplant within 12 weeks before the first infusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the safety of giving daratumumab with Lenalidomide and dexamethasone to people with MM that has come back or didn't respond to treatment.

Who is the study for?
This trial is for adults over 18 with multiple myeloma who've had 2-4 prior treatments and can receive lenalidomide and dexamethasone. Candidates must have an ECOG performance status of 0-2, indicating they are fully active or at least ambulatory. Those with a history of certain stem cell transplants, recent cancer treatments, or adverse reactions to lenalidomide aren't eligible.
What is being tested?
The study tests the safety of daratumumab combined with lenalidomide and dexamethasone in those whose multiple myeloma has returned after treatment. It's structured in two parts: first determining the safe dosage (dose escalation) and then assessing its effectiveness at that dose (dose expansion).
What are the potential side effects?
Potential side effects include immune system reactions, infusion-related responses such as fever or chills, blood count changes leading to increased infection risk or bleeding problems, fatigue, nausea, diarrhea, and possibly others related to each drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My multiple myeloma has returned after 2-4 treatments, and I can be treated with Len/Dex.
Select...
I have been treated for multiple myeloma before.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a stem cell transplant from a donor.
Select...
I had a stem cell transplant using my own cells within the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Percentage of Participants With Overall Response Rate (ORR)
Phase 2: Percentage of Participants With Overall Response Rate (ORR)
Secondary study objectives
Phase 1: Time to Response
Phase 2: Duration of Response
Phase 2: Overall Survival (OS)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DaratumumabExperimental Treatment4 Interventions
Participants will receive daratumumab along with Lenalidomide and dexamethasone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~2240
Dexamethasone
2007
Completed Phase 4
~2650

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,003 Previous Clinical Trials
6,397,897 Total Patients Enrolled
76 Trials studying Multiple Myeloma
20,068 Patients Enrolled for Multiple Myeloma
Paul Richardson, MDPrincipal InvestigatorDana Farber
11 Previous Clinical Trials
797 Total Patients Enrolled
10 Trials studying Multiple Myeloma
646 Patients Enrolled for Multiple Myeloma
Torben Plesner, MDPrincipal InvestigatorVejle Hospital
2 Previous Clinical Trials
24 Total Patients Enrolled
2 Trials studying Multiple Myeloma
24 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01615029 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Daratumumab
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT01615029 — Phase 1 & 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01615029 — Phase 1 & 2
~3 spots leftby Nov 2025
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