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Immunomodulatory Agent

Lenalidomide +/- Daratumumab for Multiple Myeloma (DRAMMATIC Trial)

Phase 3
Recruiting
Led By Amrita Krishnan, MD, FACP
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be able to take and swallow oral medication whole.
Patients must have had a confirmed diagnosis of symptomatic multiple myeloma (See Section 4.1) that required systemic induction therapy prior to autologous stem cell transplantation (ASCT).
Must not have
Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
Patients must not have known central nervous system (CNS) involvement with multiple myeloma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of intial randomization until death due to any cause, assessed up to 15 years
Awards & highlights

Summary

This trial is testing two different treatments for myeloma: Lenalidomide for 2 years, or Lenalidomide plus Daratumumab/rHuPH20. Patients will be followed for up to 15 years to see which treatment is more effective.

Who is the study for?
This trial is for adults aged 18-75 with symptomatic multiple myeloma who've had induction therapy and a stem cell transplant within the last year. They must be able to take oral meds, have good kidney and liver function, no severe lung issues or uncontrolled infections, and not allergic to study drugs. HIV-positive patients can join if their viral load is undetectable.Check my eligibility
What is being tested?
The trial tests Lenalidomide alone versus Lenalidomide plus Daratumumab/rHuPH20 as maintenance therapy post-autologous stem cell transplant (ASCT) in multiple myeloma patients. It uses MRD status after two years of treatment to decide further therapy duration, with possible treatment up to seven years.See study design
What are the potential side effects?
Potential side effects include blood clots requiring preventive treatment (DVT prophylaxis), infusion reactions from Daratumumab/rHuPH20, digestive issues due to oral medications, and risks associated with long-term immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take and swallow pills whole.
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I have multiple myeloma and received treatment before a stem cell transplant.
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I was diagnosed with multiple myeloma and received treatment before a stem cell transplant.
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I started my initial cancer treatment within the last year and have completed at least two cycles.
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I have HIV, am on treatment, and my viral load is undetectable.
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I am between 18 and 75 years old.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had severe asthma in the last 2 years and my asthma is currently under control.
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My multiple myeloma has not spread to my brain or spinal cord.
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My cancer has not worsened before signing up for this trial.
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I do not have any ongoing serious infections.
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My multiple myeloma does not only produce non-detectable levels of proteins in blood and urine.
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I have not had any organ transplants or bone marrow transplants.
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I can tolerate lenalidomide and daratumumab treatments.
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I have not failed to respond to treatments with lenalidomide or daratumumab.
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I do not have any severe illnesses that are not under control.
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My lung function is more than half of what is expected for someone my age and size.
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I do not have smoldering myeloma.
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I have not had any other types of cancer before.
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My organs are not affected by amyloidosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of intial randomization until death due to any cause, assessed up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of intial randomization until death due to any cause, assessed up to 15 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
Overall Survival
Secondary outcome measures
MRD Negativity
Progression Free Survival
Response (PR or better)
Other outcome measures
Toxicity assessment

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Lenalidomide + Daratumumab/rHuPH20Experimental Treatment2 Interventions
Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 2 years from starting treatment. Plus Daratumumab/rHuPH20 1800 mg/30,000 units D1, 8, 15, 22 q 28 days for 2 cycles, then D 1 and 15 q 28 days for cycles 3-6 then D1 q 28 days for subsequent cycles for up to 2 years from starting treatment.
Group II: Arm 2b: Stop Lenalidomide + Daratumumab/rHuPH20Active Control1 Intervention
MRD- and randomized to Arm 2b: Discontinue protocol therapy.
Group III: Arm 1a: Continue LenalidomideActive Control1 Intervention
MRD+ or MRD- and randomized to Arm 1a: Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 7 years from starting treatment.
Group IV: Arm 1b: Stop LenalidomideActive Control1 Intervention
MRD- and randomized to Arm 1b: Discontinue protocol therapy.
Group V: Study Entry / ScreeningActive Control1 Intervention
Study entry/screening to follow patient until Maintenance.
Group VI: Arm 1: LenalidomideActive Control1 Intervention
Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 2 years from starting treatment.
Group VII: Arm 2a: Continue Lenalidomide + Daratumumab/rHuPH20Active Control2 Interventions
MRD+ or MRD- and randomized to Arm 2a: Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 7 years from starting treatment. Plus Daratumumab/rHuPH20 1800 mg/30,000 units D1, 8, 15, 22 q 28 days for 2 cycles, then D 1 and 15 q 28 days for cycles 3-6 then D1 q 28 days for subsequent cycles for up to 7 years from starting treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
395 Previous Clinical Trials
264,048 Total Patients Enrolled
19 Trials studying Multiple Myeloma
6,477 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
162 Previous Clinical Trials
306,984 Total Patients Enrolled
24 Trials studying Multiple Myeloma
8,112 Patients Enrolled for Multiple Myeloma
AdaptiveUNKNOWN

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04071457 — Phase 3
Multiple Myeloma Research Study Groups: Arm 2: Lenalidomide + Daratumumab/rHuPH20, Arm 2b: Stop Lenalidomide + Daratumumab/rHuPH20, Arm 1a: Continue Lenalidomide, Arm 1b: Stop Lenalidomide, Study Entry / Screening, Arm 1: Lenalidomide, Arm 2a: Continue Lenalidomide + Daratumumab/rHuPH20
Multiple Myeloma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT04071457 — Phase 3
Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04071457 — Phase 3
~550 spots leftby Jul 2029