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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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
60%
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%
Oedema peripheral
20%
Arthralgia
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%
Musculoskeletal chest pain
10%
Muscle spasms
9%
Leukopenia
9%
Urinary tract infection
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
8%
Weight decreased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Abdominal pain
6%
Aspartate aminotransferase increased
6%
Myalgia
6%
Nasal congestion
5%
Chills
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Throat irritation
5%
Productive cough
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Acute kidney injury
2%
Atrial fibrillation
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Hip fracture
1%
Femur fracture
1%
Pulmonary sepsis
1%
Pathological fracture
1%
Squamous cell carcinoma of skin
1%
Lower Respiratory Tract Infection
1%
Rib fracture
1%
Pneumonia cytomegaloviral
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Humerus fracture
1%
Pleural effusion
1%
Respiratory failure
1%
Gastroenteritis
1%
Bronchitis chronic
1%
Febrile neutropenia
1%
Angina unstable
1%
Lower respiratory tract infection
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
Prednisone
2014
Completed Phase 4
~2370
Melphalan
2008
Completed Phase 3
~1500
Daratumumab
2014
Completed Phase 3
~1990
Bortezomib
2005
Completed Phase 2
~1060
Lenalidomide
2005
Completed Phase 2
~1070
Dexamethasone
2007
Completed Phase 4
~2590
Carfilzomib
2017
Completed Phase 3
~1400

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,384,804 Total Patients Enrolled
72 Trials studying Multiple Myeloma
19,305 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,382 Total Patients Enrolled
50 Trials studying Multiple Myeloma
14,264 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03412565 — Phase 2
Multiple Myeloma Research Study Groups: Daratumumab + Lenalidomide + Dexamethasone (D-Rd), Daratumumab + Carfilzomib + Dexamethasone (D-Kd), Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd), D + Bortezomib + Melphalan + Prednisone (D-VMP)
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT03412565 — Phase 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03412565 — Phase 2
~37 spots leftby May 2025
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