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Daratumumab Combination Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Frits van Rhee, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have high-risk disease, as defined by at least one of the following: Myeloma Prognostic Risk Signature (MyPRS) risk score ≥ 50.4, Lactate Dehydrogenase (LDH) ≥ 360 U/L (Rule out hemolysis and infection; contact PI if any doubt.), Diagnosis of primary plasma cell leukemia.
Participants must have a baseline serum creatinine level < 3 mg/dL and baseline Alanine Aminotransferase (ALT) < 3x Upper Limit of Normal (ULN).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 60 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial will study whether a newer myeloma therapy, daratumumab, can improve outcomes when added to the current standard of care.
Who is the study for?
Adults aged 18-75 with newly diagnosed active Multiple Myeloma requiring treatment, who haven't had more than four cycles of MM therapy. Must have high-risk disease indicators like a specific risk score or primary plasma cell leukemia, adequate organ function, and agree to use contraception if of childbearing potential.
What is being tested?
The trial is testing the addition of daratumumab to the Total Therapy approach for multiple myeloma. It aims to see if this new combination helps patients live longer with fewer side effects compared to current treatments.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as infusion reactions, blood disorders, kidney and liver function changes, heart issues due to drugs like Carfilzomib and Thalidomide, and general symptoms like fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is considered high-risk due to specific test results or diagnosis.
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My kidney function and liver enzymes are within the required limits.
Select...
I am between 18 and 75 years old.
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I have had 4 or fewer treatments for my multiple myeloma, excluding bisphosphonates and localized radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613444%
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%
Back Pain
10%
Pneumonia
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%
Dyspepsia
5%
Hypocalcaemia
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%
Hypophosphataemia
3%
Rash
3%
Abdominal Pain Upper
3%
Conjunctivitis
3%
Abdominal pain upper
3%
Influenza
2%
Muscle Spasms
2%
Musculoskeletal Chest Pain
2%
Muscle spasms
2%
Aspartate aminotransferase increased
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%
General physical health deterioration
1%
Hyponatraemia
1%
Condition aggravated
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
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study TreatmentExperimental Treatment12 Interventions
Induction Chemotherapy: Carfilzomib, Thalidomide, Dexamethasone, Daratumumab , CisPlatin, Adriamycin, Cyclophosphamide and Etoposide (KTD-Dara-PACE).
Autologous Stem Cell Transplant (ASCT) 1: Melphalan, Dexamethasone, ASCT.
Immunological Consolidation 1: Daratumumab.
Consolidation 1: Daratumumab, Carfilzomib, Dexamethasone (Dara-KD).
ASCT 2 (optional): Melphalan, Dexamethasone, ASCT.
Immunological Consolidation 2: Daratumumab.
Maintenance: Dara-KD alternating with Daratumumab, lenalidomide, and Dexamethasone (Dara-RD) in 3-month blocks.
Bortezomib may be substituted for carfilzomib throughout the regimen at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
FDA approved
Thalidomide
FDA approved
Dexamethasone
FDA approved
Daratumumab
FDA approved
Cisplatin
FDA approved
Doxorubicin
FDA approved
Etoposide
FDA approved
Melphalan
FDA approved
Lenalidomide
FDA approved
ASCT
2016
Completed Phase 2
~220
Cyclophosphamide
FDA approved
Bortezomib D-mannitol
FDA approved
Find a Location
Who is running the clinical trial?
Janssen, LPIndustry Sponsor
168 Previous Clinical Trials
310,335 Total Patients Enrolled
25 Trials studying Multiple Myeloma
9,613 Patients Enrolled for Multiple Myeloma
University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,497 Total Patients Enrolled
56 Trials studying Multiple Myeloma
12,108 Patients Enrolled for Multiple Myeloma
Frits van Rhee, MDPrincipal InvestigatorUniversity of Arkansas for Medical Science-Myeloma Institute
1 Previous Clinical Trials
2 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself, but my movement may be limited due to bone disease from multiple myeloma.My kidney function and liver enzymes are within the required limits.I haven't had cancer before, except for certain skin cancers or cervical cancer that's been treated, or any other cancer I haven't been treated for in the last year.I have been recently diagnosed with active Multiple Myeloma needing treatment.My condition is considered high-risk due to specific test results or diagnosis.Your blood platelet count must be at least 50,000 per microliter, unless your doctor says it's low because of a specific bone marrow condition.You need to have a test that shows your heart is pumping blood effectively, and the result needs to be at least 45%.I am between 18 and 75 years old.My condition is not considered high-risk.I do not have uncontrolled high blood pressure, diabetes, hepatitis, or other serious illnesses that could interfere with treatment.I have had 4 or fewer treatments for my multiple myeloma, excluding bisphosphonates and localized radiation.My lung function tests are above 50% of what is expected, or I have an exception due to my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Study Treatment
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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