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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to first response (pr or better) (up to 7.8 years)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary: Progression-free Survival (PFS)
Secondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,571 Total Patients Enrolled
70 Trials studying Multiple Myeloma
18,680 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,168 Total Patients Enrolled
49 Trials studying Multiple Myeloma
13,647 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Waldenström's disease or a condition with IgM protein without bone damage.I have COPD or had asthma in the last 2 years.I have or might have COPD and need a lung function test.I have been diagnosed with primary amyloidosis, MGUS, or smoldering multiple myeloma.I am using two reliable birth control methods or abstaining from sex as required.I am newly diagnosed and not eligible for intense chemotherapy due to my age or health conditions, pending sponsor approval.I have undergone radiation therapy in the last 14 days.I am a man who will use condoms and not donate sperm while on the study.I have had cancer other than multiple myeloma in the last 5 years.I have had treatment for multiple myeloma, but only emergency corticosteroids before this treatment.You have HIV, hepatitis B, or hepatitis C.I have multiple myeloma with specific symptoms or test results.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Daratumumab + Lenalidomide + Dexamethasone (DRd)
- Group 2: Lenalidomide and Dexamethasone (Rd)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other examples in the medical literature of Daratumumab + Lenalidomide + Dexamethasone (DRd) being used together?
"DRd was first trialled in 2002 and, to date, 1367 studies have completed. There are 776 clinical trials currently underway, with a large proportion being based in Berkeley, California."
Answered by AI
Does the DRd combination therapy present any dangers for patients?
"Since this is a Phase 3 trial, there is both efficacy and safety data available. This makes DRd a 3 on our Power team's safety scale."
Answered by AI
How many different medical clinics are running this clinical trial today?
"Presently, this clinical trial is enrolling patients at 91 sites. The sites are based in cities such as Berkeley, Frederick, Fort Lauderdale, and others. If you enroll, try to select a clinic near you to limit travel."
Answered by AI
What are the primary medical conditions that DRd is used to treat?
"DRd, which is a combination of daratumumab, lenalidomide, and dexamethasone, is most often used to treat ophthalmia, sympathetic. Additionally, this medication can be used to ameliorate symptoms associated with at least two prior systemic chemotherapy regimens, branch retinal vein occlusion, and macular edema."
Answered by AI
Would I be able to sign up for this research project right now?
"This particular study is not currently looking for more participants, as it was last updated over 3 years ago. However, there are 826 other studies concerning multiple myeloma that are recruiting patients and 776 studies for Daratumumab + Lenalidomide + Dexamethasone (DRd) that are currently active."
Answered by AI
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