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Immunomodulatory agents

Daratumumab vs Lenalidomide for Multiple Myeloma

Phase 2
Recruiting
Led By Urvi Shah, MBBS
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects who have had ASCT may enroll following minimum 100-day washout per standard guidelines
Subjects agree to not donate eggs/sperm for 3 months following cessation of daratumumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will compare the quality of life for patients with newly diagnosed MM who respond well to initial treatment, between those who receive the standard maintenance therapy (lenalidomide) and those who receive daratumumab as maintenance therapy.

Who is the study for?
This trial is for people with newly diagnosed multiple myeloma who've responded well to initial treatment. They must be able to take antiviral and anticoagulation meds, understand the consent form, and women of childbearing age must avoid pregnancy and adhere to REMS program requirements. Participants should have proper kidney, liver function, and agree to birth control measures.Check my eligibility
What is being tested?
The study compares usual maintenance therapy (lenalidomide) with daratumumab as a new option for maintaining health in multiple myeloma patients post-treatment. Quality of life will be assessed through questionnaires to determine if daratumumab offers better outcomes than lenalidomide.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as infusion reactions from Daratumumab or Lenalidomide, blood disorders like anemia or clotting issues due to prophylactic anticoagulants, potential infections from lowered immunity, and various organ-specific inflammations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a stem cell transplant over 100 days ago.
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I agree not to donate eggs/sperm for 3 months after stopping daratumumab.
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I agree to use birth control during and for 3 months after my treatment.
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I finished my initial cancer treatment less than 7 months ago due to delays.
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I am a woman who can have children and have tested negative for pregnancy before starting Lenalidomide.
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I agree to use a condom during sex, even though I've had a vasectomy.
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I can take daily medication to prevent blood clots.
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I can take care of myself but might not be able to do heavy physical work.
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My myeloma treatment has shown a very good response or better.
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I can take medication to prevent viral infections.
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My kidney function, measured by creatinine clearance, is at least 40 mL/min.
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I am interested in the nutrition intervention but understand it's optional for the study.
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I am 18 years old or older.
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I agree to follow the pregnancy testing schedule as required.
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My white blood cell count is healthy enough for treatment.
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My blood, kidney, and liver functions are all within normal ranges.
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I will use effective birth control during and for 3 months after daratumumab treatment.
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I am a woman who could potentially become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Difference in the global health status
Secondary outcome measures
difference in overall survival and progression-free survival

Trial Design

2Treatment groups
Experimental Treatment
Group I: Lenalidomide maintenanceExperimental Treatment3 Interventions
Those randomized to lenalidomide maintenance will receive a maintenance dose of 10mg oral lenalidomide on days 1-21 of each 28-day cycle. HRQoL with EORTC QLQ-C30, EORTC QLQ-MY20 and PRO-CTCAE questionnaires will be collected: prior to therapy initiation (baseline); day 1 of cycle 2 and every cycle day 1 thereafter; at therapy discontinuation, and at 1-month post therapy follow-up. ARM A1: The first 15 patients on each arm interested in this sub study will be enrolled during C10D1 visit to initiate whole food plant based diet (WFPBD) meals and nutrition counseling on C13D1 for 12 weeks followed by additional 12 weeks of counseling alone from C16D1. They will continue on their lenalidomide maintenance schedule per study calendar. ARM A2: The patients who do not go on the nutrition sub study will continue on their lenalidomide maintenance schedule per study calendar.
Group II: Daratumumab maintenanceExperimental Treatment3 Interventions
Those randomized to receive daratumumab maintenance will receive 1800 milligrams (mg) subcutaneous (SC) injection of daratumumab as follows: days 1, 8, 15, and 22 of cycles 1 and 2; days 1 and 15 of cycles 3-6; day 1 of cycles 7-36. HRQoL with EORTC QLQ-C30, EORTC QLQ-MY20 and PRO-CTCAE questionnaires will be collected: prior to therapy initiation (baseline); day 1 of cycle 2 and every cycle day 1 thereafter; at therapy discontinuation, and at 1-month post therapy follow-up. ARM B1: The first 15 patients on each arm interested in this sub study will be enrolled during C10D1 visit to initiate whole food plant based diet (WFPBD) meals and nutrition counseling on C13D1 for 12 weeks followed by additional 12 weeks of counseling alone from C16D1. They will continue on their daratumumab maintenance schedule per study calendar. ARM B2: The patients who do not go on the nutrition sub study will continue on their daratumumab maintenance schedule per study calendar.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1860
Questionnaires
2013
Completed Phase 2
~3330
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,520 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,067 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,418 Total Patients Enrolled
23 Trials studying Multiple Myeloma
1,996 Patients Enrolled for Multiple Myeloma
Urvi Shah, MBBSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Multiple Myeloma
150 Patients Enrolled for Multiple Myeloma

Media Library

Lenalidomide (Immunomodulatory agents) Clinical Trial Eligibility Overview. Trial Name: NCT04497961 — Phase 2
Multiple Myeloma Research Study Groups: Daratumumab maintenance, Lenalidomide maintenance
Multiple Myeloma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT04497961 — Phase 2
Lenalidomide (Immunomodulatory agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04497961 — Phase 2

Frequently Asked Questions

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

Is there still an opportunity for patients to join this experiment?

"Indeed, according to clinicaltrials.gov this investigation is presently enrolling participants; the trial was published on August 28th 2020 and last edited on August 8th 2022."

Answered by AI

To what extent is Daratumumab commonly used to treat various illnesses?

"Daratumumab is frequently used to address chronic lymphocytic leukemia, but can also be useful for other conditions like immunomodulation, after two or more chemotherapy treatments, and amyloidosis."

Answered by AI

Has Daratumumab officially received regulatory approval?

"Due to the lack of evidence supporting Daratumumab's efficacy, our team at Power assigned it a safety score of 2 on a scale from 1 to 3."

Answered by AI

In what areas is the research project accessible?

"At present, 7 medical centres are actively enrolling participants in this trial. These sites can be found near Commack, Middletown and Harrison as well as other nearby areas - selecting the closest location will help to reduce travel time if you choose to get involved."

Answered by AI

What is the enrolment cap for this clinical trial?

"Confirmed. Clinicaltrials.gov reveals that this experiment, which was initiated on August 28th 2020 and recently updated on the 8th of August 2022, is currently open to new patients with a goal of recruiting 100 individuals from 7 locations."

Answered by AI

Are there any records of previous research involving Daratumumab?

"Daratumumab has been studied for nearly two decades, with 541 completed trials and 360 still in progress. The major hub of these studies is located at the Midwest Center for Hematology Oncology and Commack, New york."

Answered by AI
~6 spots leftby Aug 2024