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Monoclonal Antibodies

Subcutaneous Daratumumab for High-Risk Smoldering Multiple Myeloma

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Diagnosis of high risk smoldering multiple myeloma (SMM) (per International Myeloma Working Group [IMWG] criteria) for less than or equal to (<=) 5 years with measurable disease at the time of randomization, defined as serum M protein greater than or equal to (>=) 10 gram per liter (g/L) or urine M protein >= 200 milligram per 24 hours (mg/24 hours) or involved serum free light chain (FLC) >=100 milligram per liter (mg/L) and abnormal serum FLC ratio

Must not have

Exposure to investigational drug (including investigational vaccines) or invasive investigational medical device for any indication within 4 weeks or 5 half-lives, whichever is longer, before Cycle 1, Day 1

Ongoing treatment with corticosteroids with a dose >10 milligram (mg) prednisone or equivalent per day at the time of randomization; or >280 mg cumulative prednisone dose or equivalent for any 4-week period in the year prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 8 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effects of a new medication given as a shot under the skin to active monitoring in people with a high risk of developing a blood cancer.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Daratumumab may cause side effects such as reactions at the injection site, fatigue, nausea, fever, chills, coughing and shortness of breath during infusion; it can also affect blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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

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I am using or willing to use effective birth control or abstain from sex.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not used any experimental drugs or devices in the last 4 weeks or longer.

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I am currently taking more than 10mg of corticosteroids daily or have taken a high dose in the past year.

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I am not currently on treatments like infliximab or methotrexate that could affect the study.

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I have previously been treated with daratumumab or other anti-CD38 therapies.

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I have been diagnosed with AL amyloidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 8 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

Progression-free Survival (PFS)

Secondary study objectives

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score

Change From Baseline in European Quality (EuroQoL) 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale

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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

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.

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