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Immunomodulatory Agent

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

Phase 3
Recruiting
Led By Parameswaran Hari, MD
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 have adequate hepatic function.
Patients must be able to take and swallow oral medication whole.
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

DRAMMATIC Trial 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.

DRAMMATIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is working well.
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I can take and swallow pills whole.
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My kidney function is normal.
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I can go back to the transplant center for my treatment.
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I am eligible for a transplant or had one within the last 6 months.
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I had a physical exam within the last 28 days.
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I am willing and able to take medication to prevent blood clots.
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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 am between 18 and 75 years old.
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I will provide samples for minimal residual disease testing and future research.
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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.

DRAMMATIC Trial 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

DRAMMATIC 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 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 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 2b: Stop Lenalidomide + Daratumumab/rHuPH20Active Control1 Intervention
MRD- and randomized to Arm 2b: Discontinue protocol therapy.
Group V: Study Entry / ScreeningActive Control1 Intervention
Study entry/screening to follow patient until Maintenance.
Group VI: Arm 1b: Stop LenalidomideActive Control1 Intervention
MRD- and randomized to Arm 1b: Discontinue protocol therapy.
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
~1480

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,070 Total Patients Enrolled
19 Trials studying Multiple Myeloma
6,477 Patients Enrolled for Multiple Myeloma
AdaptiveUNKNOWN
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
260,711 Total Patients Enrolled
19 Trials studying Multiple Myeloma
6,477 Patients Enrolled for Multiple Myeloma

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04071457 — Phase 3
Multiple Myeloma Research Study Groups: Arm 1: Lenalidomide, Arm 2: Lenalidomide + Daratumumab/rHuPH20, Arm 1a: Continue Lenalidomide, Arm 2b: Stop Lenalidomide + Daratumumab/rHuPH20, Study Entry / Screening, Arm 1b: Stop 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

Frequently Asked Questions

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

For which type of patient is this clinical trial looking for volunteers?

"The study's aim is to enroll 1100 patients that have a diagnosis of multiple myeloma and are between 18 to 75 years old."

Answered by AI

Are they looking for more test subjects at this time?

"That is accurate. The online information hub for clinical trials, clinicaltrials.gov, has the latest update that this trial is looking for 1100 patients from 100 sites. The trial was first posted on 6/27/2019."

Answered by AI

Are there precedent treatments that use Daratumumab/rHuPH20?

"The first study involving daratumumab/rHuPH20 took place in 2004 at University of Wisconsin Carbone Cancer Center. As of right now, there have been a total of 418 completed trials. Presently, there are 395 clinical trials actively recruiting participants, a majority of which are based in Durham, North carolina."

Answered by AI

How many subjects are participating in this clinical trial?

"Janssen, LP is sponsoring this clinical trial which requires 1100 participants that meet the inclusion criteria. This study will be conducted at various sites, two of which are Duke University Medical Center in Durham, North carolina and Oklahoma Cancer Specialists and Research Institute-Tulsa in Tulsa, Oklahoma."

Answered by AI

Is this clinical trial restricted to senior citizens?

"This trial is enrolling individuals that fall between 18 to 75 years old."

Answered by AI

Can Daratumumab/rHuPH20 be legally obtained in the United States?

"The safety of Daratumumab/rHuPH20 has been well established in Phase 3 trials, so our team has given it a score of 3."

Answered by AI

What are the top indications for Daratumumab/rHuPH20?

"Daratumumab/rHuPH20 can be used to treat patients who have already tried other systemic chemotherapy regimens. Additionally, this medication can be used to treat inflammatory breast cancer (ibc), amyloidosis, and refractory multiple myeloma."

Answered by AI

Who else is applying?

What state do they live in?
British Columbia
What site did they apply to?
PeaceHealth Saint Joseph Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~587 spots leftby Jul 2029