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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study 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.Check my eligibility

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).See study design

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

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My multiple myeloma has returned after 2-4 treatments, and I can be treated with Len/Dex.

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I have been treated for multiple myeloma before.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Percentage of Participants With Overall Response Rate (ORR)

Phase 2: Percentage of Participants With Overall Response Rate (ORR)

Secondary outcome measures

Phase 1: Time to Response

Phase 2: Duration of Response

Phase 2: Overall Survival (OS)

+3 more

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

~1480

Dexamethasone

2007

Completed Phase 4

~2590

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,263 Total Patients Enrolled

70 Trials studying Multiple Myeloma

19,372 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people will this clinical trial be able to help?

"As of right now, this study is not looking for any more candidates. This specific trial was first posted on 6/26/2012 and updated for the last time on 11/3/2022. There are 827 other studies currently recruiting patients with multiple myeloma and 777 studies actively searching for participants in Part 1 (Dose Escalation): Daratumumab."

Answered by AI

Can people with certain medical conditions enroll in this trial currently?

"This particular trial is no longer recruiting patients, as indicated by the clinicaltrials.gov website. This study was first posted on June 26th, 2012 and last updated on November 3rd, 2020. There are 1604 other trials that are currently looking for participants."

Answered by AI

What is the first stage of daratumumab treatment?

"Part 1 (Dose Escalation) of the Daratumumab treatment can be used to help patients with ophthalmia, sympathetic, at least two prior systemic chemotherapy regimens, and branch retinal vein occlusion."

Answered by AI

What are the goals that researchers hope to achieve with this trial?

"The primary objective of this trial is to Phase 1: Percentage of Participants With Overall Response Rate (ORR). Secondary objectives include Phase 2: Time to Response, which is defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better), and Phase 2: Overall Survival (OS), which is defined as overall survival from administration of the first infusion (Day 1) until death. Median Overall Survival will be estimated by using the Kaplan Meier method. Additionally, in Phase 2 we will measure Duration of Response, calculated from the date of initial documentation of a"

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

Monocytes and Granulocytes Reduce CD38 Expression Levels on Myeloma Cells in Patients Treated with Daratumumab

Krejcik, Jakub, Kris A. Frerichs, Inger S. Nijhof, Berris van Kessel, Jeroen F. van Velzen, Andries C. Bloem, Marloes E.C. Broekmans, et al.. 2017. “Monocytes and Granulocytes Reduce CD38 Expression Levels on Myeloma Cells in Patients Treated with Daratumumab”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-17-2027.

BloodJournal

Phase 1/2 Study of Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma

Plesner, Torben, Hendrik-Tobias Arkenau, Peter Gimsing, Jakub Krejcik, Charlotte Lemech, Monique C. Minnema, Ulrik Lassen, et al.. 2016. “Phase 1/2 Study of Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma”. Blood. American Society of Hematology. doi:10.1182/blood-2016-07-726729.

BloodJournal

Phase 1/2 Study of Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma

clinicaltrials.govStudy

Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma