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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
Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy
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 belowSelect...
I had a stem cell transplant over 100 days ago.
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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 18 years old or older.
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My white blood cell count is healthy enough for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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
~1990
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
1,937 Previous Clinical Trials
588,220 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not participating in the nutrition sub-study.I do not have any uncontrolled illnesses or social situations that would affect my study participation.My condition did not improve or worsened while on lenalidomide or daratumumab.You have tested positive for hepatitis C.Your platelet count is at least 50,000 per microliter.I have had moderate to severe asthma in the past 2 years or currently have uncontrolled asthma.I had a stem cell transplant over 100 days ago.I agree not to donate eggs/sperm for 3 months after stopping daratumumab.I agree to use birth control during and for 3 months after my treatment.I had a severe reaction to thalidomide or lenalidomide.My multiple myeloma is getting worse despite treatment.I do not have any conditions that affect drug absorption.I finished my initial cancer treatment less than 7 months ago due to delays.I am a woman who can have children and have tested negative for pregnancy before starting Lenalidomide.I agree to use a condom during sex, even though I've had a vasectomy.I can take daily medication to prevent blood clots.I agree not to breastfeed while receiving daratumumab treatment.I have had a stem cell transplant from a donor.I can take care of myself but might not be able to do heavy physical work.I cannot take certain blood thinners or antiviral medications.I have COPD with less than half the normal lung function.I am on constant medication to suppress my immune system.My myeloma treatment has shown a very good response or better.Your hemoglobin level is equal to or greater than 8 grams per deciliter.My language is not supported for the cancer quality of life surveys.You are allergic to legumes.I can take medication to prevent viral infections.My kidney function, measured by creatinine clearance, is at least 40 mL/min.Your total bilirubin levels should be less than 2 mg/dL, except if you have Gilbert's syndrome. Also, your AST and ALT levels should be less than 3 times the upper limit of normal.I have not had major surgery in the last month.I am interested in the nutrition intervention but understand it's optional for the study.My HIV is under control and undetectable.I have been diagnosed with plasma cell leukemia.I have had an organ transplant and am on immunosuppressive drugs.I have not had a heart attack in the last 6 months and do not have severe heart issues.I agree not to breastfeed while I am being treated with lenalidomide.My high blood pressure or diabetes is not under control and I am not seeing a doctor for it.You have a positive test for hepatitis B surface antigen (HBsAg).I have received treatment for early-stage multiple myeloma.I am not on any experimental treatments for myeloma, but I may be taking bisphosphonates or denosumab.I have no ongoing side effects from previous treatments, except for hair loss or nerve issues.I have severe nerve damage.I am 18 years old or older.I agree to follow the pregnancy testing schedule as required.My white blood cell count is healthy enough for treatment.My blood, kidney, and liver functions are all within normal ranges.I will use effective birth control during and for 3 months after daratumumab treatment.You have a severe allergy to cashew nuts, but not to peanuts.I haven't had cancer, except for non-dangerous skin cancer or localized cancer that was fully removed, in the last 3 years.I have no active or remaining signs of a previous cancer.This criterion means that the participant should be interested in trying a diet consisting mainly of plants and plant-based recipes.I am a woman who could potentially become pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Daratumumab maintenance
- Group 2: Lenalidomide maintenance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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