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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 48 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
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 ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure the progression-free survival in patients with high risk multiple myeloma
Side 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
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
159 Previous Clinical Trials
307,390 Total Patients Enrolled
23 Trials studying Multiple Myeloma
9,132 Patients Enrolled for Multiple Myeloma
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,303 Total Patients Enrolled
54 Trials studying Multiple Myeloma
11,930 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a fresh endeavor in research?
"Starting in 1997, Alfacell sponsored a trial of 300 patients to research the effects of Daratumumab. After receiving Phase 3 Drug approval following this initial study, there are now 2351 active trials for Daratumumab occurring across 86 nations and 4157 cities."
Answered by AI
Are participants aged 40+ eligible for this experiment?
"This medical trial is looking to enrol people aged 18 or older, but under 75 years of age."
Answered by AI
Are there any potential risks associated with the utilization of Daratumumab?
"Our team at Power determined that Daratumumab is likely safe enough to rate a 2. This assessment was based on the fact that it's currently in Phase 2 and there are some studies affirming its safety, but none attesting to its efficacy."
Answered by AI
Am I eligible to join this research endeavor?
"This clinical trial is seeking to enroll 50 adults aged between 18 and 75 with a diagnosis of multiple myeloma. Additional eligibility criteria include: an Eastern Cooperative Oncology Group (ECOG) score no higher than 2, MyPRS risk score above 50.4, newly diagnosed active MM requiring treatment or evidence of progressive disease in patients who have previously been treated for smouldering myeloma, not more than four cycles of systemic MM therapy prior to enrolment into the study such as RD or VRD therapies are allowed but bisphosphonates and localized radiation treatments must be completed before enrollment., minimum age set at 18 years"
Answered by AI
Are participants able to enroll in this experiment at this current moment?
"The data on clinicaltrials.gov indicates that this medical study is not currently seeking participants, as it was last updated in September 1st 2022. Despite this trial's conclusion, there are still 3158 other trials actively recruiting patients at present."
Answered by AI
In what capacities is Daratumumab commonly employed?
"Daratumumab is most frequently administered to patients whose prior therapies have been unsuccessful. Its application can also be extended to various other illnesses such as biological response modifiers, kaposi's sarcoma aids related, and merkel cell cancer."
Answered by AI
How many subjects is this clinical trial recruiting?
"This experiment is no longer recruiting participants, as it was initially posted on July 1st 2017 and last updated September 1st 2022. For those looking for alternative clinical trials, there are 807 studies that involve multiple myeloma, while 2351 experiments actively search for Daratumumab patients."
Answered by AI
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