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Proteasome Inhibitor
Daratumumab-Based Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Rachid C Baz, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Calculated creatinine clearance >/=30ml/min by Cockcroft-Gault formula
Eastern Cooperative Group (ECOG) Performance Status of 0 - 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing daratumumab-based therapies for older adults with multiple myeloma.
Who is the study for?
This trial is for older adults (65+) with newly diagnosed multiple myeloma who haven't had chemotherapy but may have had palliative radiotherapy or a small dose of dexamethasone. They must be able to follow the study schedule, use contraception if necessary, and have adequate organ function and bone marrow capacity. People with severe other illnesses, active infections requiring IV antibiotics, certain viral infections (HIV, hepatitis B/C), or uncontrolled medical conditions are excluded.Check my eligibility
What is being tested?
The study tests daratumumab-based therapies combined with oral dexamethasone, lenalidomide pills, and bortezomib injections in treating multiple myeloma in older adults. It's designed to see how well patients respond to this combination therapy without undergoing high-dose chemotherapy with stem-cell transplantation due to their age or coexisting conditions.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site for daratumumab and bortezomib; increased risk of infection; blood clots; fatigue; nausea; diarrhea from lenalidomide and dexamethasone; as well as possible liver toxicity indicated by changes in blood tests.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are functioning well enough, as per a specific test.
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I am able to get out of my bed or chair and move around.
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My blood tests show I have enough white blood cells and platelets.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Overall Survival
Progression Free Survival
Other outcome measures
Number of Participants who Continue on Arm A after 2 cycles
Number of Participants without Minimal Residual Disease
Trial Design
3Treatment groups
Experimental Treatment
Group I: C: Daratumumab, Dexamethasone and BortezomibExperimental Treatment3 Interventions
Participants who have less than a partial response to Arm A may have Bortezomib added to their treatment. Bortezomib will be given weekly in subcutaneous injections at a starting dose of 1/3 mg/m^2 Days 1,8 and 15 of each 28 day treatment cycle.
Group II: B: Daratumumab, Dexamethasone and LenalidomideExperimental Treatment3 Interventions
Participants who have less than a partial response to Arm A may have Lenalidomide added to their treatment. Lenalidomide will be given orally on days 1-21 of each 28 day treatment cycle.
Group III: A: Daratumumab & DexamethasoneExperimental Treatment2 Interventions
All participants will receive 1800 mg in 15 ml Daratumumab by subcutaneous injection weekly and be given 20 mg of Dexamethasone orally once a week for 2 months. Patients who receive a partial response or better will continue on this arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone Oral
2020
N/A
~14110
Bortezomib Injection
2018
Completed Phase 2
~210
Daratumumab Injection
2020
Completed Phase 2
~20
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,459 Total Patients Enrolled
29 Trials studying Multiple Myeloma
2,080 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,485 Total Patients Enrolled
23 Trials studying Multiple Myeloma
2,063 Patients Enrolled for Multiple Myeloma
Rachid C Baz, MDPrincipal InvestigatorH. Lee Moffitt Cancer & Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have high levels of a protein called paraprotein in your blood or urine.I am over 65 and have health issues that may worsen with intense chemotherapy.My kidneys are functioning well enough, as per a specific test.You have tested positive for hepatitis C.Your bilirubin levels in the blood should not be more than 1.5 times the upper limit of the normal range.My only sign of plasma cell disorder is a single bone or soft tissue tumor.I agree to use a condom during sex if my partner can get pregnant, even though I've had a vasectomy.I am able to get out of my bed or chair and move around.I am not allergic to the study drugs, hyaluronidase, monoclonal antibodies, human proteins, or their components.I have severe COPD or asthma that's been hard to control in the last 2 years.You have tested positive for HIV.You have been diagnosed with hepatitis B.My hemoglobin level is above 8 g/dL, transfusions included.My blood tests show I have enough white blood cells and platelets.Your AST or ALT levels in the blood are not more than twice the upper limit of normal.I am not using any cancer treatments except for hormonal therapy.I've been cancer-free for 2 years, except for certain skin cancers or in-situ cervical cancer.I am currently receiving IV antibiotics for a severe infection.I do not have unmanaged health issues like heart disease, high blood pressure, or diabetes.I have active multiple myeloma but haven't had chemotherapy for it.
Research Study Groups:
This trial has the following groups:- Group 1: C: Daratumumab, Dexamethasone and Bortezomib
- Group 2: A: Daratumumab & Dexamethasone
- Group 3: B: Daratumumab, Dexamethasone and Lenalidomide
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.
Has Daratumumab Injection completed the FDA's approval process?
"There is some clinical data supporting the Daratumumab Injection's safety, but none for efficacy; this earned it a score of 2."
Answered by AI
Are we still receiving applications for this experiment?
"This trial, which was published on clinicaltrials.gov on 11/22/2019, is still recruiting patients for participation and editied most recently on 9/30/2022."
Answered by AI
What are the primary reasons that Daratumumab Injection is prescribed?
"Daratumumab Injection is most often given to patients suffering from ophthalmia, sympathetic. It has also been shown to be an effective treatment for at least two prior systemic chemotherapy regimens, branch retinal vein occlusion, and macular edema."
Answered by AI
How many people can enroll in this research program?
"The information available on clinicaltrials.gov supports that this study is searching for volunteers to participate. The trial was originally advertised on November 22nd, 2019 and the most recent update was September 30th, 2022. They are 1 centres looking for a total of 32 patients."
Answered by AI
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