Your session is about to expire
← Back to Search
Monoclonal Antibodies
Quadruple Drug Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Shaji Kumar
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat multiple myeloma. The drugs work in different ways to stop the growth of cancer cells.
Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who are in good physical condition, can consent to the study's requirements, agree to use birth control, and have not had extensive prior treatments. They must have certain blood counts and organ function levels within set limits and cannot be pregnant or nursing.Check my eligibility
What is being tested?
The trial tests a combination of ixazomib citrate (which blocks enzymes needed for cancer cell growth), lenalidomide and dexamethasone (chemotherapy drugs that kill or stop cancer cells from growing), along with daratumumab (a monoclonal antibody targeting cancer cells).See study design
What are the potential side effects?
Possible side effects include fatigue, digestive issues like diarrhea, increased risk of infections due to low blood counts, potential allergic reactions to the drugs' components, nerve pain or damage known as neuropathy, and liver problems indicated by elevated enzyme levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.
Select...
I am able to care for myself and perform daily activities.
Select...
I have myeloma and have had minimal or no treatment, but some specific treatments are okay.
Select...
My multiple myeloma can be measured by medical tests.
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
Proportion of patients who achieve a confirmed Complete Response (CR)
Secondary outcome measures
Incidence of adverse events
Overall Response Rate (ORR)
Overall Survival (OS)
+2 moreOther outcome measures
Minor Response Development (MRD)
Neurotoxicity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ixazomib, lenalidomide, daratumumab, dexamethasone)Experimental Treatment6 Interventions
INDUCTION PHASE: Patients receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-21. Patients receive daratumumab IV over 3-7 hours on days 1, 8, 15, and 22 of courses 1 and 2, on days 1 and 15 of courses 3, 4, and 5, and on day 1 of courses 7 and beyond. Patients also receive dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive ixazomib citrate PO on days 1, 8, and 15 and daratumumab IV over 3-7 hours on day 1. Courses repeat every 28 days for up to 36 months from registration in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Lenalidomide
FDA approved
Daratumumab
FDA approved
Ixazomib
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,587 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,050 Patients Enrolled for Multiple Myeloma
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,003 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,631 Patients Enrolled for Multiple Myeloma
Shaji KumarPrincipal InvestigatorMayo Clinic
15 Previous Clinical Trials
1,614 Total Patients Enrolled
15 Trials studying Multiple Myeloma
1,614 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.I have a stomach or intestine condition that affects how I absorb pills or have trouble swallowing.You have enough infection-fighting white blood cells in your body.Your hemoglobin level is at least 8.0 grams per deciliter.Your total bilirubin levels are not more than 1.5 times the upper limit of normal.I haven't had any cancer other than non-melanoma skin cancer or in situ carcinoma, or if I have, it was more than 2 years ago and fully treated.I am not on any other experimental treatments but can take bisphosphonates.My heart condition is stable and any ECG irregularities are not a concern.You have hepatitis B or active hepatitis C infection.I am able to care for myself and perform daily activities.I have myeloma and have had minimal or no treatment, but some specific treatments are okay.You are okay with giving bone marrow and blood samples for research.I haven't taken any strong medication that affects liver enzymes in the last 2 weeks.My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.I experience significant numbness, tingling, or pain in my hands or feet.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study.I had radiotherapy less than 2 weeks ago, or 1 week ago for a small area.You are allergic to corticosteroids, monoclonal antibodies, human proteins, or any ingredients in these medications.I am of childbearing age and do not plan to use birth control.I have been diagnosed with MGUS or smoldering myeloma.Your platelet count without receiving a blood transfusion is 75,000 or higher per cubic millimeter.Your liver enzymes (ALT and AST) are not more than 2.5 times the normal upper limit.I don't have any serious health or mental conditions that could stop me from completing the treatment.I am currently breastfeeding.I have not had major surgery in the last 14 days.I have mild or no diarrhea without taking medicine for it.My multiple myeloma can be measured by medical tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ixazomib, lenalidomide, daratumumab, dexamethasone)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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.
Does Daratumumab carry a high risk for adverse side effects?
"Since this is a phase 2 trial, there is only preliminary data supporting the safety of Daratumumab. No efficacy data exists yet."
Answered by AI
What are some of the primary medical conditions that Daratumumab has been approved to treat?
"Daratumumab is most often used to treat ophthalmia and sympathetic. However, it can also be helpful for patients suffering from at least two prior systemic chemotherapy regimens, branch retinal vein occlusion, and macular edema."
Answered by AI
Are we currently able to enroll patients in this research project?
"This study is not accepting patients at the moment. The first posting was on April 12th, 2017 and there was a September 8th, 2022 update. However, if you're looking for other trials, 839 are enrolling patients with multiple myeloma while 794 studies are recruiting participants who Daratumumab might help."
Answered by AI
What is the projected or expected enrollment for this clinical trial?
"Presently, this clinical trial is not recruiting new patients. The study was originally advertised on April 12th, 2017 and underwent its most recent edit on September 8th, 2022. If you are seeking other trials, there are 839 active studies for multiple myeloma and 794 for Daratumumab that presently have open enrollment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger