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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
Must have documented multiple myeloma and measurable disease
Must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen
Must not have
Has received any of the following therapies: daratumumab or other anti-CD38 therapies
Disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to date of death due to any cause (up to 87.5 months)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial looks at whether adding daratumumab to lenalidomide and dexamethasone improves progression-free survival in people with relapsed or refractory multiple myeloma.

Who is the study for?
This trial is for people with multiple myeloma who've had at least one prior treatment and showed some response. They must have worsening disease after their last therapy, be fairly active (ECOG score 0-2), and not have used certain drugs recently. Those allergic to lenalidomide or who've had a stem cell transplant too close to the study start are excluded.
What is being tested?
The study tests if adding Daratumumab to Lenalidomide and Dexamethasone (DRd) improves survival without cancer progression compared to just Lenalidomide and Dexamethasone (Rd) in those whose multiple myeloma has returned or resisted treatment.
What are the potential side effects?
Possible side effects include immune system reactions, infusion-related responses from Daratumumab, blood clots due to Lenalidomide, and high blood sugar or bone thinning from Dexamethasone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have confirmed multiple myeloma with measurable signs.
Select...
I have had treatment for multiple myeloma and responded to it.
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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:
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I have been treated with daratumumab or similar medications.
Select...
My condition didn't improve or worsened with lenalidomide, or I had a bad reaction to it.
Select...
I have had a stem cell transplant recently or plan to have one before my disease worsens.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to date of death due to any cause (up to 87.5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to date of death due to any cause (up to 87.5 months) 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
Duration of Response (DOR)
Overall Response Rate
Overall Survival (OS)
+5 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
44%
Thrombocytopenia
38%
Peripheral sensory neuropathy
38%
Peripheral Sensory Neuropathy
32%
Anaemia
24%
Fatigue
22%
Diarrhoea
17%
Upper respiratory tract infection
17%
Upper Respiratory Tract Infection
16%
Constipation
15%
Insomnia
15%
Asthenia
13%
Cough
11%
Nausea
11%
Neuralgia
11%
Pyrexia
11%
Dizziness
10%
Back Pain
10%
Pneumonia
10%
Back pain
10%
Neutropenia
9%
Dyspnoea
8%
Oedema peripheral
8%
Oedema Peripheral
7%
Pain in extremity
7%
Hyperglycaemia
6%
Pain in Extremity
6%
Arthralgia
6%
Headache
6%
Paraesthesia
6%
Bronchitis
5%
Bone pain
5%
Epistaxis
5%
Bone Pain
5%
Decreased Appetite
5%
Hypocalcaemia
5%
Dyspepsia
5%
Leukopenia
5%
Hypokalaemia
5%
Decreased appetite
4%
Lymphopenia
4%
Oedema
4%
Vomiting
4%
Hypotension
4%
Alanine aminotransferase increased
4%
Abdominal pain
4%
Nasopharyngitis
4%
Alanine Aminotransferase Increased
3%
Hypertension
3%
Rash
3%
Abdominal Pain Upper
3%
Conjunctivitis
3%
Hypophosphataemia
3%
Abdominal pain upper
3%
Influenza
2%
Muscle Spasms
2%
Musculoskeletal Chest Pain
2%
Aspartate aminotransferase increased
2%
Muscle spasms
2%
Urinary tract infection
2%
Myalgia
2%
Herpes zoster
2%
Musculoskeletal chest pain
2%
Herpes Zoster
1%
Pulmonary Embolism
1%
Weight Decreased
1%
Pulmonary embolism
1%
Myocardial infarction
1%
Dehydration
1%
Myocardial Infarction
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
Condition aggravated
1%
General physical health deterioration
1%
Hyponatraemia
1%
Orthostatic hypotension
1%
Lower respiratory tract infection
1%
Syncope
1%
Productive cough
1%
Nasal congestion
1%
Respiratory failure
1%
Weight decreased
1%
Chills
1%
Gastroenteritis
1%
Sepsis
1%
Respiratory Failure
1%
Condition Aggravated
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bortezomib + Dexamethasone (Vd)
Daratumumab + Bortezomib and Dexamethasone (DVd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

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: Daratumumab + lenalidomide + dexamethasoneExperimental Treatment3 Interventions
During each 28-day treatment cycle, participants will receive daratumumab, lenalidomide, and dexamethasone.
Group II: Lenalidomide + dexamethasoneActive Control2 Interventions
During each 28-day treatment cycle, participants will receive lenalidomide and dexamethasone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~2000
Lenalidomide
2005
Completed Phase 3
~2240
Dexamethasone
2007
Completed Phase 4
~2650

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,004 Previous Clinical Trials
6,402,238 Total Patients Enrolled
76 Trials studying Multiple Myeloma
19,544 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
770 Previous Clinical Trials
3,977,978 Total Patients Enrolled
53 Trials studying Multiple Myeloma
14,465 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02076009 — Phase 3
Multiple Myeloma Research Study Groups: Daratumumab + lenalidomide + dexamethasone, Lenalidomide + dexamethasone
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT02076009 — Phase 3
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02076009 — Phase 3
~50 spots leftby Nov 2025
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