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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have confirmed multiple myeloma with measurable signs.
Select...
I have had treatment for multiple myeloma and responded to it.
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 date of death due to any cause (up to 87.5 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to date of death due to any cause (up to 87.5 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Duration of Response (DOR)
Overall Response Rate
Overall Survival (OS)
+5 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Pain in extremity
14%
Lymphopenia
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Bone pain
9%
Leukopenia
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Alanine aminotransferase increased
8%
Weight decreased
8%
Abdominal pain upper
8%
Muscle Spasms
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Abdominal pain
6%
Nasal congestion
6%
Aspartate aminotransferase increased
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Pleural effusion
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Femur fracture
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Respiratory failure
1%
Bronchitis chronic
1%
Squamous cell carcinoma of skin
1%
Humerus fracture
1%
Gastroenteritis
1%
Pathological fracture
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
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
~1860
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,739 Total Patients Enrolled
70 Trials studying Multiple Myeloma
18,848 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,336 Total Patients Enrolled
49 Trials studying Multiple Myeloma
13,815 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with daratumumab or similar medications.I haven't had cancer, except for certain skin cancers or early-stage cancers deemed cured, in the last 5 years.I have confirmed multiple myeloma with measurable signs.I've waited the required time after my last cancer treatment before starting daratumumab.My condition didn't improve or worsened with lenalidomide, or I had a bad reaction to it.I have received treatment for myeloma within the last 2 weeks or before 5 half-lives of the treatment passed.You must have proof that your disease has gotten worse according to specific guidelines.I have had treatment for multiple myeloma and responded to it.I have had a stem cell transplant recently or plan to have one before my disease worsens.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
- Group 2: Lenalidomide + dexamethasone
Awards:
This trial has 2 awards, including:- 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.
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 the research facilities for this experiment widely dispersed geographically?
"At the moment, this clinical trial is looking for patients from 33 different medical sites. These locations include Quebec City and Toronto in Canada, West Palm Beach in America, and 30 other places. If you want to enroll, try to pick a location that is close to where you live to limit travel."
Answered by AI
How many people can enroll in this clinical trial?
"This particular trial is no longer looking for patients as of its most recent update on November 3rd, 2022. The trial was first posted on May 23rd, 2014. There are 826 other trials involving multiple myeloma that are actively recruiting and 777 trials concerning Daratumumab."
Answered by AI
Has Daratumumab undergone the necessary regulatory testing to be available for public use?
"Since this is a Phase 3 trial, there is already some data to support the efficacy of Daratumumab. Furthermore, because there have been multiple rounds of testing for safety, our team rates the safety as a 3."
Answered by AI
What does the existing research on Daratumumab tell us?
"Daratumumab was first studied in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. To date, there have been 1369 completed trials and 777 ongoing studies. Many of the recruiting centres for these active trials are located in Quebec City and Florida."
Answered by AI
What are some of the main conditions that Daratumumab is used to treat?
"Daratumumab is often used to treat ophthalmia, sympathetic. It has also shown efficacy in treating branch retinal vein occlusion, macular edema, and in patients that have already undergone two rounds of systemic chemotherapy."
Answered by AI
Can more people join this research project?
"As of right now, this particular trial is not looking for new patients. The clinical trial was first posted on May 23rd, 2014 and updated November 3rd, 2022. There are 826 other trials actively recruiting multiple myeloma patients and 777 active trials enrolling Daratumumab participants."
Answered by AI
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