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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
No Placebo-Only Group
Pivotal 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.
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.
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 belowSelect...
I can take and swallow pills whole.
Select...
I have multiple myeloma and received treatment before a stem cell transplant.
Select...
I was diagnosed with multiple myeloma and received treatment before a stem cell transplant.
Select...
I started my initial cancer treatment within the last year and have completed at least two cycles.
Select...
I have HIV, am on treatment, and my viral load is undetectable.
Select...
I am between 18 and 75 years old.
Select...
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:Select...
I haven't had severe asthma in the last 2 years and my asthma is currently under control.
Select...
My multiple myeloma has not spread to my brain or spinal cord.
Select...
My cancer has not worsened before signing up for this trial.
Select...
I do not have any ongoing serious infections.
Select...
My multiple myeloma does not only produce non-detectable levels of proteins in blood and urine.
Select...
I have not had any organ transplants or bone marrow transplants.
Select...
I can tolerate lenalidomide and daratumumab treatments.
Select...
I have not failed to respond to treatments with lenalidomide or daratumumab.
Select...
I do not have any severe illnesses that are not under control.
Select...
My lung function is more than half of what is expected for someone my age and size.
Select...
I do not have smoldering myeloma.
Select...
I have not had any other types of cancer before.
Select...
My organs are not affected by amyloidosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of intial randomization until death due to any cause, assessed up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of intial randomization until death due to any cause, assessed up to 15 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival
Secondary study objectives
MRD Negativity
Progression Free Survival
Response (PR or better)
Other study objectives
Toxicity assessment
Side effects data
From 2024 Phase 1 trial • 9 Patients • NCT04714372100%
Febrile neutropenia
100%
Hypoalbuminemia
100%
Hyperphosphatemia
100%
Typhlitis
100%
Chills
100%
Portal vein thrombosis
100%
Cytokine release syndrome
100%
Abdominal infection
100%
Platelet count decreased
100%
Hypokalemia
100%
Hypophosphatemia
100%
Generalized muscle weakness
100%
Arterial thromboembolism
100%
Other, specify - Disease progression
100%
Nausea
100%
Anemia
100%
Fever
100%
Lymphocyte count decreased
100%
Hypomagnesemia
100%
Hypocalcemia
100%
Anorexia
100%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~2240
Daratumumab/rHuPH20
2021
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
264,516 Total Patients Enrolled
19 Trials studying Multiple Myeloma
6,477 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
168 Previous Clinical Trials
309,285 Total Patients Enrolled
25 Trials studying Multiple Myeloma
8,563 Patients Enrolled for Multiple Myeloma
AdaptiveUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver is working well.I haven't had severe asthma in the last 2 years and my asthma is currently under control.I started my initial cancer treatment within the last year and have completed at least two cycles.I can take and swallow pills whole.My kidney function is normal.I can go back to the transplant center for my treatment.I am eligible for a transplant or had one within the last 6 months.My multiple myeloma has not spread to my brain or spinal cord.I had a physical exam within the last 28 days.My cancer has not worsened before signing up for this trial.You are eligible if your disease can be measured using a blood test that shows at least 100 mg/L of the involved light chain.I am willing and able to take medication to prevent blood clots.I do not have any ongoing serious infections.All the medical tests to determine the current state of the disease must be completed within 60 days before starting the study. The results of these tests will be recorded on specific forms.My multiple myeloma does not only produce non-detectable levels of proteins in blood and urine.I have multiple myeloma and received treatment before a stem cell transplant.I was diagnosed with multiple myeloma and received treatment before a stem cell transplant.I have not had any organ transplants or bone marrow transplants.I can tolerate lenalidomide and daratumumab treatments.I am registered for the first part of the trial and have finished my initial treatment.I will provide samples for minimal residual disease testing and future research.I have HIV, am on treatment, and my viral load is undetectable.I have not failed to respond to treatments with lenalidomide or daratumumab.I do not have any severe illnesses that are not under control.My lung function is more than half of what is expected for someone my age and size.I do not have smoldering myeloma.I have not had any other types of cancer before.I am between 18 and 75 years old.I can take care of myself but might not be able to do heavy physical work.My organs are not affected by amyloidosis.You should not have hepatitis C.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Lenalidomide + Daratumumab/rHuPH20
- Group 2: Arm 2b: Stop Lenalidomide + Daratumumab/rHuPH20
- Group 3: Arm 1a: Continue Lenalidomide
- Group 4: Arm 1b: Stop Lenalidomide
- Group 5: Study Entry / Screening
- Group 6: Arm 1: Lenalidomide
- Group 7: Arm 2a: Continue Lenalidomide + Daratumumab/rHuPH20
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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