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Monoclonal Antibodies
Daratumumab-based Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Matthew Pianko, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Baseline bone marrow or tissue sample available for Clonality ID in ClonoSEQ
Participant must be registered in and must comply with all requirements of REMSTM program for lenalidomide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after week 88, up to 3 years after start of study treatment
Awards & highlights
Study Summary
This trial will test whether a new combination therapy of drugs will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care.
Who is the study for?
This trial is for adults with newly diagnosed Multiple Myeloma who have measurable disease and can tolerate treatments, including high-dose chemotherapy and stem cell transplant if needed. Participants must not have had more than one cycle of myeloma therapy before joining, be free from certain blood/liver diseases, HIV, Hepatitis B/C, other active cancers in the last five years, or significant heart or lung conditions.Check my eligibility
What is being tested?
The study tests a combination of drugs (daratumumab + lenalidomide + dexamethasone) as initial treatment. If minimal residual disease is detected afterward, an additional drug (bortezomib) is added. The approach adapts to each patient's response to maximize chances of eliminating all signs of cancer at a microscopic level.See study design
What are the potential side effects?
Possible side effects include immune system reactions like infusion-related symptoms with daratumumab; blood clots and skin rash with lenalidomide; weight gain and mood changes with dexamethasone; and nerve damage or digestive issues with bortezomib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a bone marrow or tissue sample available for testing.
Select...
I am registered and comply with the REMS program for lenalidomide.
Select...
I am a man willing to follow specific rules about contraception or abstinence.
Select...
I have been diagnosed with active multiple myeloma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after week 88, up to 3 years after start of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after week 88, up to 3 years after start of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants who achieve MRD negativity either after induction or, if still MRD-positive after induction, after consolidation.
Secondary outcome measures
Health-related quality of life assessment changes from baseline using EuroQol survey "EQ-5D."
Incidence of treatment-emergent adverse events
Neurotoxicity assessment changes from baseline using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire.
+7 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%
Nasal congestion
6%
Musculoskeletal Chest Pain
6%
Myalgia
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%
Pleural effusion
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%
Pathological fracture
1%
Femur 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: Dara-Rd followed by Dara-RVdExperimental Treatment4 Interventions
Induction regimen with Daratumumab, Lenalidomide and Dexamethasone (Dara-Rd) in all study subjects, weeks 1-24
Consolidation regimen with Daratumumab, Lenalidomide, Bortezomib and Dexamethasone (Dara-RVd) in post-induction MRD+ population, weeks 25-36
Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88
Maintenance regimen with lenalidomide (R) until progression or intolerance
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1860
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590
Bortezomib
2005
Completed Phase 2
~1140
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,040 Total Patients Enrolled
11 Trials studying Multiple Myeloma
457 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,461 Total Patients Enrolled
23 Trials studying Multiple Myeloma
2,039 Patients Enrolled for Multiple Myeloma
Matthew Pianko, M.D.Principal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or cannot take certain medications required for this study.I have a bone marrow or tissue sample available for testing.I am registered and comply with the REMS program for lenalidomide.I am not pregnant or breastfeeding.I am a man willing to follow specific rules about contraception or abstinence.I am eligible for a stem cell transplant and can handle all treatments for my myeloma.I meet the specific requirements for women regarding menopause, sterility, pregnancy testing, contraception, and abstinence.I have tested positive for HIV, Hepatitis B, or Hepatitis C.My cancer has spread to my brain or spinal cord.I have had a stem cell transplant before.I am not using strong drugs that affect liver enzyme CYP3A4, or I can switch them.I have had another type of cancer in the last 5 years.I have been diagnosed with a specific blood or bone marrow condition.I am at least 18 years old or the legal age in my country.I can care for myself and am deemed fit for treatment by my doctor.My cancer can be measured by tests.My kidneys are not working well, with a creatinine clearance below 30ml/min.My liver function tests are within normal limits.Abnormal results in blood tests and other lab tests.I have had only one cycle of treatment for my myeloma.I haven't had major surgery in the last 2 weeks or still recovering from one.I have no major heart, lung, or other serious health issues.I have been diagnosed with active multiple myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: Dara-Rd followed by Dara-RVd
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.
How is Daratumumab typically used?
"Daratumumab is commonly used to treat ophthalmia, sympathetic. Daratumumab can also be effective at treating other conditions like branch retinal vein occlusion, macular edema, and at least two prior systemic chemotherapy regimens."
Answered by AI
In how many different locations is this trial being conducted?
"Currently, this trial is enrolling patients from 4 clinical sites. While the locations of these centres are Detroit, Dallas and Rochester among others, it may be beneficial for participants to choose a site closest to them in order to limit travel."
Answered by AI
How many individuals are enrolled in this research project?
"That is right, the information available on clinicaltrials.gov reveals that this study is looking for volunteers. This research was first advertised on October 5th 2020 and has seen some updates since then, with the most recent being July 18th 2022. The trial requires 50 individuals from 4 different sites."
Answered by AI
What are some comparable studies to Daratumumab that have already been completed?
"Daratumumab was first studied in 2002 at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, there have been 1632 completed trials with 814 live trials as of now. A significant number of these ongoing studies are based in Detroit and Texas."
Answered by AI
When did the FDA give their okay to Daratumumab?
"The safety of Daratumumab was given a score of 2 by our team because, while there is data supporting its safety, none exists yet for its efficacy."
Answered by AI
Are we enrolling new patients at this time?
"That is accurate. The website clinicaltrials.gov has the latest information on this topic. According to their records, this trial was originally posted on 10/5/2020. Most recently, it was updated on 7/18/2022. They are looking for 50 patients that will be dispersed between 4 different sites."
Answered by AI
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