Daratumumab + Lenalidomide for Multiple Myeloma
(AURIGA Trial)

Recruiting in Palo Alto (17 mi)

+87 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing whether adding daratumumab to lenalidomide is more effective than using lenalidomide alone for patients with newly diagnosed multiple myeloma. These patients still have detectable cancer cells after initial treatments. Daratumumab helps the immune system find and kill cancer cells, while lenalidomide boosts the immune system and stops cancer growth.

Eligibility Criteria

This trial is for individuals with newly diagnosed multiple myeloma who have had at least 4 cycles of induction therapy, a stem cell transplant within the last year, and are still showing minimal residual disease. They should be in relatively good health (ECOG score 0-2) and not have been treated with Daratumumab or similar drugs before.

Inclusion Criteria

I have remaining cancer cells detected by a specific blood test.

I was diagnosed with multiple myeloma, had 4+ treatment cycles, a stem cell transplant within a year of starting treatment, and it's been less than 6 months since my transplant.

I have bone marrow samples or MRD test results from before my treatment.

+2 more

Exclusion Criteria

You have a known history of testing positive for HIV, hepatitis B, or hepatitis C, unless you have been vaccinated for hepatitis B or have successfully cleared hepatitis C virus from your body.

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

I have not had Daratumumab or similar treatments, recent radiation (except for symptom relief), or plasmapheresis in the last 28 days.

+4 more

Participant Groups

The study tests if adding Daratumumab to Lenalidomide maintenance treatment helps patients achieve negative status for minimal residual disease compared to using Lenalidomide alone after a stem cell transplant in those who haven't previously received CD38-targeting treatments.

2Treatment groups

Experimental Treatment

Active Control

Group I: Daratumumab + LenalidomideExperimental Treatment2 Interventions

Participants will receive 1800 milligram (mg) daratumumab by subcutaneous (SC) injection in combination with lenalidomide (orally) as maintenance therapy for a maximum of 36 cycles. Each cycle is of 28 days.

Group II: LenalidomideActive Control1 Intervention

Participants will receive lenalidomide (orally) alone as maintenance therapy for a maximum of 36 cycles. Each cycle is of 28 days.

Lenalidomide is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Revlimid for: