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Immunomodulatory agents

Daratumumab vs Lenalidomide for Multiple Myeloma

Phase 2

Recruiting

Led By Urvi A Shah, MD, MS

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

Must not have

Uncontrolled intercurrent illness including but not limited to uncontrolled infection or psychiatric illness/social situations that would compromise compliance with study requirements

History of disease refractory to lenalidomide or daratumumab, as defined by the IMWG as failure to achieve minimal response or development of progressive disease while on therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses or social situations that would affect my study participation.

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My condition did not improve or worsened while on lenalidomide or daratumumab.

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I have had moderate to severe asthma in the past 2 years or currently have uncontrolled asthma.

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I had a severe reaction to thalidomide or lenalidomide.

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My multiple myeloma is getting worse despite treatment.

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I do not have any conditions that affect drug absorption.

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I agree not to breastfeed while receiving daratumumab treatment.

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I have had a stem cell transplant from a donor.

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I cannot take certain blood thinners or antiviral medications.

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I have COPD with less than half the normal lung function.

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I am on constant medication to suppress my immune system.

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I have not had major surgery in the last month.

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My HIV is under control and undetectable.

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I have been diagnosed with plasma cell leukemia.

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I have had an organ transplant and am on immunosuppressive drugs.

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I have not had a heart attack in the last 6 months and do not have severe heart issues.

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I agree not to breastfeed while I am being treated with lenalidomide.

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My high blood pressure or diabetes is not under control and I am not seeing a doctor for it.

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I have no ongoing side effects from previous treatments, except for hair loss or nerve issues.

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I have severe nerve damage.

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I have no active or remaining signs of a previous cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in the global health status

Secondary study objectives

difference in overall survival and progression-free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Lenalidomide maintenanceExperimental Treatment3 Interventions

Arm A: 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. Sub ARM A: 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 provided by Daily Harvest and nutrition counseling for 12 weeks. They will continue on their lenalidomide maintenance schedule per study calendar. 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

ARM B: 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. Sub ARM B: 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 provided by Daily Harvest and nutrition counseling for 12 weeks. They will continue on their daratumumab maintenance schedule per study calendar. 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

~2380

Questionnaires

2013

Completed Phase 2

~4280