← Back to Search

Monoclonal Antibodies

Daratumumab + Lenalidomide + Dexamethasone for 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

Participant must have documented multiple myeloma satisfying the CRAB (calcium elevation, renal insufficiency, anemia and bone abnormalities) criteria, monoclonal plasma cells in the bone marrow >= 10%, or presence of a biopsy proven plasmacytoma and measurable disease as defined by specific criteria for different types of myeloma

Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

Must not have

Participant has a diagnosis of Waldenström's disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions

Participant has known chronic obstructive pulmonary disease (COPD) or a history of asthma within the last 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to first response (pr or better) (up to 7.8 years)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare two treatments for people with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy and stem cell transplant. The first treatment is daratumumab in combination with lenalidomide and dexamethasone. The second treatment is lenalidomide and dexamethasone. The study will look at how well each treatment works in terms of progression-free survival (PFS).

Who is the study for?

This trial is for adults with newly diagnosed multiple myeloma who can't have high-dose chemotherapy and stem cell transplant. They must meet specific criteria including certain blood and bone marrow conditions, agree to use effective contraception, and have a performance status score of 0-2, indicating they are relatively active.

What is being tested?

The study tests if adding Daratumumab (given by injection under the skin or into a vein) to Lenalidomide and Dexamethasone improves survival without cancer progression in new multiple myeloma patients compared to just Lenalidomide and Dexamethasone.

What are the potential side effects?

Possible side effects include immune system reactions, infusion-related reactions from Daratumumab, risk of infections, blood clots, fatigue, constipation or diarrhea due to Lenalidomide; plus increased sugar levels and mood changes from Dexamethasone.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have multiple myeloma with specific symptoms or test results.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

Select...

I have been diagnosed with Waldenström's disease or a condition with IgM protein without bone damage.

Select...

I have COPD or had asthma in the last 2 years.

Select...

I have been diagnosed with primary amyloidosis, MGUS, or smoldering multiple myeloma.

Select...

I have had cancer other than multiple myeloma in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to first response (pr or better) (up to 7.8 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to first response (pr or better) (up to 7.8 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to first response (pr or better) (up to 7.8 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

Primary: Progression-free Survival (PFS)

Secondary study objectives

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12

+10 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Daratumumab + Lenalidomide + Dexamethasone (DRd)Active Control3 Interventions

Participants will receive Daratumumab 16 milligram per kilogram (mg/kg) by intravenous infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks, Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study completion. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.

Group II: Lenalidomide and Dexamethasone (Rd)Active Control3 Interventions

Participants will receive Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.

0 / 6Eligibility criteria met