Subcutaneous Daratumumab for High-Risk Smoldering Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+207 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?

The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

Eligibility Criteria

This trial is for people diagnosed with high-risk smoldering multiple myeloma (SMM) within the last 5 years, who have measurable disease and meet specific criteria like certain protein levels in blood/urine. They should be relatively healthy otherwise, able to perform daily activities with little or no assistance (ECOG score of 0 or 1), and women must use effective contraception. People can't join if they've had previous treatments for SMM/MM, certain bone lesions, severe kidney issues, recent other cancers except minor skin cancers or localized prostate cancer.

Inclusion Criteria

I have been diagnosed with a high-risk type of early-stage multiple myeloma within the last 5 years.

If you are a woman who could become pregnant, you need to have a negative pregnancy test within 14 days before starting the study.

I am fully active or can carry out light work.

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Exclusion Criteria

You have more than one small spot in your body that is bigger than 5 millimeters when checked with MRI.

My kidney function is low, not due to multiple myeloma.

I have previously received treatments for SMM or MM, but I am on stable doses of medication for bone health.

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Treatment Details

Interventions

Daratumumab SC (Monoclonal Antibodies)

Trial OverviewThe study tests whether daratumumab given under the skin prolongs the time patients live without their disease getting worse compared to just watching and waiting. Daratumumab is an antibody that targets cancer cells. Participants will either receive this drug subcutaneously along with rHuPH20 (an enzyme to help absorption) or undergo active monitoring without treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Daratumumab SCExperimental Treatment1 Intervention

Participants will receive 1800 milligram (mg) of daratumumab co-formulated with 2000 units per milliliter (U/mL) of recombinant human hyaluronidase (rHuPH20) by subcutaneous (SC) injection until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion.

Group II: Arm A: Active MonitoringActive Control1 Intervention

Participants randomized to active monitoring will receive no study medication, but will undergo the same disease evaluations at the same frequency as participants randomized to daratumumab.

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

🇪🇺 Approved in European Union as Darzalex for: