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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 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 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

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

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 • NCT04714372

67%

Edema limbs

67%

Diarrhea

67%

Vomiting

67%

Nausea

50%

Epistaxis

50%

Febrile neutropenia

50%

Anemia

50%

Fever

50%

Platelet count decreased

33%

White blood cell decreased

33%

Fatigue

33%

Sepsis

33%

Neutrophil count decreased

33%

Anorexia

33%

Hypokalemia

33%

Hypertension

33%

Constipation

33%

Gastrointestinal disorders - Other, specify

33%

General disorders and administration site conditions - Other, specify

33%

Other, specify - Disease progression

33%

Headache

33%

Infections and infestations - Other, specify

17%

Back pain

17%

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

17%

Aspartate aminotransferase increased

17%

Cardiac disorders - Other, specify

17%

Hyponatremia

17%

Atrial fibrillation

17%

Heart failure

17%

Sinus tachycardia

17%

Injection site reaction

17%

Pain

17%

Alanine aminotransferase increased

17%

Creatinine increased

17%

Hypophosphatemia

17%

Nervous system disorders - Other, specify

17%

Paresthesia

17%

Dysuria

17%

Nasal congestion

17%

Pleural effusion

17%

Thromboembolic event

17%

Insomnia

17%

Alopecia

17%

Pericardial effusion

17%

Mucositis oral

17%

Enterocolitis infectious

17%

Viremia

17%

Hypoalbuminemia

17%

Pain in extremity

17%

Hallucinations

17%

Hypoxia

17%

Erythema multiforme

17%

Hypotension

17%

Hematuria

17%

Lymphocyte count decreased

100%

80%

60%

40%

20%

Study treatment Arm

Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose

Dose Level 1: FT538 at 1 x10^8 Cells/Dose

Dose Level 2: FT538 at 3 x10^8 Cells/Dose

Dose Level 3: FT538 at 1 x10^9 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