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Monoclonal Antibody
Daratumumab Combination Therapy for Multiple Myeloma
Phase 1
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 up to 30 days after the last dose of study medication
Awards & highlights
Study Summary
This trial is testing how safe and tolerable daratumumab is when given with other treatments for multiple myeloma.
Who is the study for?
This trial is for adults with multiple myeloma. Eligible participants include those newly diagnosed (for the KRd regimen) or with relapsed/refractory disease (for the CFZ-dex regimen), having a performance status score of 0-2, and meeting certain lab value criteria. Exclusions apply to those with significant heart disease, neuropathy, other specific medical conditions, prior anti-CD38 therapy use, or recent malignancies.Check my eligibility
What is being tested?
The study tests daratumumab's safety and dosage in combination with various treatments like Lenalidomide and Carfilzomib for multiple myeloma. It aims to find out how well patients tolerate this mix of drugs and what dosages are most effective.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, nerve pain issues (neuropathy), and possibly heart-related complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after the last dose of study medication
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after the last dose of study medication
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Number of participants affected by dose-limiting toxicities
Secondary outcome measures
Complete response rate
Duration of response
Maximum observed concentration of daratumumab
+2 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
6Treatment groups
Experimental Treatment
Group I: Daratumumab + VTDExperimental Treatment6 Interventions
Daratumumab will be administered with Velcade-thalidomide-dexamethasone (VTD).
Group II: Daratumumab + VMPExperimental Treatment6 Interventions
Daratumumab will be administered with Velcade-melphalan-prednisone (VMP).
Group III: Daratumumab + VDExperimental Treatment5 Interventions
Daratumumab will be administered with Velcade-dexamethasone (VD).
Group IV: Daratumumab + Pom-dexExperimental Treatment5 Interventions
Daratumumab will be administered with pomalidomide-dexamethasone (Pom-dex).
Group V: Daratumumab + KRdExperimental Treatment7 Interventions
Daratumumab will be administered with carfilzomib- lenalidomide-dexamethasone (KRd) regimen.
Group VI: Daratumumab + CFZ-dexExperimental Treatment6 Interventions
Daratumumab will be administered with carfilzomib (CFZ)-dexamethasone (CFZ-dex) regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Daratumumab
2014
Completed Phase 3
~1860
Velcade
2006
Completed Phase 4
~1320
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590
Montelukast
2008
Completed Phase 4
~15460
Acetaminophen
2017
Completed Phase 4
~2030
Carfilzomib
2017
Completed Phase 3
~1440
Lenalidomide
2005
Completed Phase 3
~1480
Melphalan
2008
Completed Phase 3
~1500
Thalidomide
2001
Completed Phase 4
~3050
Diphenhydramine
2002
Completed Phase 4
~1170
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,068 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,177 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,665 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,144 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have plasma cell leukemia or POEMS syndrome.You have a serious heart condition.You have moderate or severe peripheral neuropathy or nerve pain.Showing signs of multiple myeloma spreading to the meninges.If you have just been diagnosed with myeloma, you can join if the treatment is carfilzomib-lenalidomide-dexamethasone (KRd). If you have relapsed or refractory myeloma, you can join if the treatment is carfilzomib-dexamethasone (CFZ-dex).You have been diagnosed with symptomatic multiple myeloma and have measurable signs of the disease.You have previously been treated with daratumumab or other medicines that target CD38.You have certain blood conditions like amyloidosis or multiple myeloma with specific proteins present.You had another type of cancer, other than multiple myeloma, within the last 5 years.You have long-term breathing problems like COPD or persistent asthma, or you had asthma in the past 2 years.You have tested positive for HIV, hepatitis B, or hepatitis C.You are in good enough health to carry out daily activities and self-care.Your lab test results must meet specific values before starting the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Daratumumab + VMP
- Group 2: Daratumumab + VTD
- Group 3: Daratumumab + KRd
- Group 4: Daratumumab + Pom-dex
- Group 5: Daratumumab + CFZ-dex
- Group 6: Daratumumab + VD
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.
Is Daratumumab a new or experimental medication?
"City of Hope Comprehensive Cancer Center began studying daratumumab in 1997 and, since then, 3303 clinical trials have been completed. There are currently 1316 ongoing studies, a majority of which are being conducted out of Duarte, California."
Answered by AI
Does this trial have a wide geographic reach?
"Currently, this study is enrolling patients at 10 different locations. The sites are situated in Duarte, New york, Charlotte and 8 other cities. If you are looking to participate in this trial, try and select a location near you to limit travel."
Answered by AI
Has the Daratumumab drug been cleared by the FDA?
"Given that this is a Phase 1 trial, there is only limited data to support the safety and efficacy of Daratumumab. Consequently, our team has given it a score of 1."
Answered by AI
How is Daratumumab most frequently used?
"Daratumumab is often used to manage macular edema, but it can also be used to treat other conditions like ulcerative colitis, varicella-zoster virus acute retinal necrosis, and more."
Answered by AI
How many research participants will this study be taking on?
"826 other clinical trials are actively recruiting patients with multiple myeloma and 1316 trials are searching for participants for Daratumumab."
Answered by AI
Are there any vacant positions in this clinical trial for potential participants?
"This study is not currently looking for patients to enroll, as seen by the last update on the trial being from November 3rd, 2022. 826 other clinical trials are searching for patients with multiple myeloma and 1316 trials are searching for patients that might respond to Daratumumab."
Answered by AI
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