Your session is about to expire
← Back to Search
Monoclonal Antibodies
Daratumumab for Multiple Myeloma
Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for d-vrd arm: baseline up to 2 years 3 months; for d-vmp, d-rd and d-kd arms: baseline up to 2 years 7 months
Awards & highlights
Study Summary
This trial will test if daratumumab can help treat multiple myeloma when used with other standard treatments. The goal is to see if it can improve overall response rates or rates of very good partial response.
Who is the study for?
This trial is for adults with Multiple Myeloma who have measurable levels of M-protein or light chains in their blood or urine. Participants should be relatively fit (ECOG grade 0-2) and either newly diagnosed or have relapsed/refractory disease after one prior therapy including lenalidomide. They must not have severe asthma, uncontrolled pulmonary diseases, active hepatitis B/C, HIV, certain other cancers within the last two years, or meningeal involvement by myeloma.Check my eligibility
What is being tested?
The study tests how well daratumumab works when given under the skin alongside standard treatments for Multiple Myeloma. The effectiveness will be measured by response rates to treatment combinations like Daratumumab with bortezomib, melphalan, prednisone; lenalidomide plus dexamethasone; and carfilzomib with dexamethasone.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site due to subcutaneous administration of daratumumab and common chemotherapy-related issues such as nausea, fatigue, risk of infections due to lowered immunity, possible nerve damage from drugs like bortezomib and blood clots from drugs like lenalidomide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for d-vrd arm: baseline up to 2 years 3 months; for d-vmp, d-rd and d-kd arms: baseline up to 2 years 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for d-vrd arm: baseline up to 2 years 3 months; for d-vmp, d-rd and d-kd arms: baseline up to 2 years 7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR)
D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response
Secondary outcome measures
D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR)
D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate
D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response
+6 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%
Lymphopenia
14%
Pain in extremity
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%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Nasal congestion
6%
Aspartate aminotransferase increased
6%
Abdominal pain
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%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
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%
Femur fracture
1%
Pleural effusion
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
4Treatment groups
Experimental Treatment
Group I: Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)Experimental Treatment4 Interventions
Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
Group II: Daratumumab + Lenalidomide + Dexamethasone (D-Rd)Experimental Treatment3 Interventions
Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.
Group III: Daratumumab + Carfilzomib + Dexamethasone (D-Kd)Experimental Treatment3 Interventions
Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.
Group IV: D + Bortezomib + Melphalan + Prednisone (D-VMP)Experimental Treatment4 Interventions
Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500
Prednisone
2014
Completed Phase 4
~2370
Daratumumab
2014
Completed Phase 3
~1860
Bortezomib
2005
Completed Phase 2
~1140
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590
Carfilzomib
2017
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,043 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,152 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,640 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,119 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- One of these conditions must apply to you:You have asthma that is not well controlled and it has been moderate or severe for a long time, or you have had asthma in the past 2 years.You have a lung disease that affects your breathing or have high blood pressure in your lungs.To provide an accurate and understandable summary, I would need you to list the specific criteria that follow the introductory statement "Any of the following." Please provide the full list of criteria for me to summarize.You have recently been diagnosed with myeloma and are eligible for treatment with the D-VRd or D-VMP regimens.You have a disease that has come back or is not responding to previous treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
- Group 2: Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
- Group 3: Daratumumab + Lenalidomide + Dexamethasone (D-Rd)
- Group 4: D + Bortezomib + Melphalan + Prednisone (D-VMP)
Awards:
This trial has 1 awards, including:- 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.
What medical purpose does Daratumumab typically serve?
"Daratumumab is a popular medication for managing ophthalmia and sympathetic, as well as branch retinal vein occlusion, macular edema, and other conditions which have proven resistant to two systemic chemotherapies."
Answered by AI
What additional testing has been done regarding the efficacy of Daratumumab?
"Presently, 1143 medical studies related to Daratumumab are in progress with 249 of those trials situated within Phase 3. A plethora of 38663 sites worldwide have been enlisted for the purpose of investigating this medication and a considerable amount are located around Joliet, Illinois."
Answered by AI
Has Daratumumab been officially sanctioned by the FDA?
"Taking into account only the safety data that exists, Daratumumab was assigned a score of 2. This is because it has been through Phase 2 clinical trials, meaning there are some supporting findings on its security but no evidence in regards to efficacy."
Answered by AI
How many locations within the state have been enlisted to conduct this clinical experiment?
"Individuals looking to join the trial can expect to be accepted by Mayo Clinic in Jacksonville, Florida; UF Health Cancer Center at Orlando Health in Orlando, Michigan and Karmonos Cancer Institute in Detroit, Nebraska. Additionally, there are 16 other sites offering enrollment opportunities."
Answered by AI
Are any fresh volunteers being accepted for the experiment?
"Evidently, the trial in question is not enrolling patients as per information on clinicaltrials.gov. This study was initially uploaded onto the site on April 26th 2018 and its records were most recently updated November 22nd 2022. Although this investigation has closed recruitment, there are 1950 other trials seeking participants currently active."
Answered by AI
How many trial participants have been involved in this research?
"This trial is no longer available for enrollment. It was initially announced on April 26th 2018 and the last update came in November 22nd 2022. Other possible opportunities exist, with 807 studies actively seeking participants with multiple myeloma, and 1143 trials recruiting patients using Daratumumab as a medication."
Answered by AI
What are the fundamental goals of this experiment?
"This clinical trial aims to assess the overall response rate (ORR) of D-VMP, D-Kd, and D-Rd cohorts over a period lasting up to 10 months after patient enrolment. Secondary objectives include evaluating the number of participants with anti-drug antibodies against daratumumab or recombinant human hyaluronidase (rHuPH20), maximum observed serum concentrations (Cmax) of daratumumab, and percentage of patients who experience infusion related reactions (IRRs)."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger