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Monoclonal Antibodies
Quad Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Caitlin Costello, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of Multiple Myeloma having received 1 and 3 prior lines of treatment
All pts must have received prior lenalidomide therapy and been determined to be relapsed and/or refractory.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will test how effective the Daratumumab, Ixazomib, Pomalidomide and Dexamethasone combination is for Multiple Myeloma patients.
Who is the study for?
This trial is for adults with Multiple Myeloma who've had 1-3 prior treatments but haven't used Daratumumab or Ixazomib before. They must not be pregnant, agree to birth control measures, and join the POMALYST REMS program. Participants should have a life expectancy over 3 months, an ECOG status of 0-2, and adequate organ function.Check my eligibility
What is being tested?
The study tests a combination therapy using Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone in patients with relapsed/refractory Multiple Myeloma. It aims to evaluate the overall response rate to this salvage therapy regimen.See study design
What are the potential side effects?
Potential side effects include blood clots requiring aspirin or anticoagulants; risk of infections; possible allergic reactions; liver issues due to hepatic function requirements; fatigue from dexamethasone; and gastrointestinal problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Multiple Myeloma and have been treated 1 to 3 times before.
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I have taken lenalidomide before and my condition worsened or didn't improve.
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My white blood cell and hemoglobin levels are within the required range.
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I agree to follow the pregnancy testing schedule as required.
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I have not worsened while on pomalidomide.
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My cancer has returned or is not responding to treatment.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Overall Response Rate
Secondary outcome measures
Clinical benefit rate
Minimal Residual Disease (MRD)
Overall survival (OS)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ixazomib, daratumumab, pomalidomide and dexamethasoneExperimental Treatment4 Interventions
Daratumumab will be administered at 16mg/kg IV weekly x 8 weeks, biweekly x 8 weeks, then monthly. Pomalidomide 4mg will be administered orally daily for days 1-21. Patients ≤ age 75 will receive a 40mg dose of dexamethasone, and those over the age of 75 may receive a 20mg dose of dexamethasone orally on days 1, 8, 15, and 22 (weekly). Ixazomib will be administered 4mg orally on days 1, 8 and 15.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
2017
Completed Phase 4
~3370
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,589 Total Patients Enrolled
1 Trials studying Multiple Myeloma
729 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,925 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,817 Patients Enrolled for Multiple Myeloma
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,216 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,187 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition did not improve after taking pomalidomide.My liver is working well.I agree to use two forms of birth control or abstain from sex for 120 days after the last dose.I have previously used daratumumab or ixazomib.I am HIV positive or suspected to be.My multiple myeloma has spread to my brain or spinal cord.I agree to take daily aspirin or, if I have a history of blood clots, to be on full anticoagulation treatment.Your platelet count is at least 75,000 per microliter of blood (or at least 50,000 per microliter if bone marrow plasma cells make up more than half of the cellularity).I have not had major surgery in the last 3 weeks.I haven't had any cancer besides nonmelanoma skin cancer or carcinoma in situ, or if I have, it was more than 2 years ago and fully treated.I have an active hepatitis infection.I have or might have amyloidosis affecting an organ.I am allergic to some specific cancer drugs or their ingredients.I have Multiple Myeloma and have been treated 1 to 3 times before.My white blood cell and hemoglobin levels are within the required range.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I haven't taken specific strong medications or St. John's wort in the last 14 days.I have no stomach or intestine problems that affect how I absorb pills.I have taken lenalidomide before and my condition worsened or didn't improve.I am not pregnant or breastfeeding.I am a woman who can have children and have a negative pregnancy test.I agree to follow the pregnancy testing schedule as required.You cannot have taken part in a research study testing a new treatment within the last 3 weeks or within 5 times the half-life of the drug before starting this trial. However, if you participated in a study that only observed people and did not involve any new treatments, you can still join this trial.I have not worsened while on pomalidomide.I have been diagnosed with moderate or severe asthma in the last 2 years.My multiple myeloma does not produce high levels of antibodies.I have severe COPD with less than half the normal lung function.I am a man and agree to use a condom during the study and for 120 days after it ends.My kidneys are working well.I am informed about pregnancy risks and precautions every month.I haven't had radiotherapy to multiple sites or immunotherapy within the last 2 weeks.I have not taken antibiotics, antivirals, or antifungals for an infection in the last two weeks.My cancer has returned or is not responding to treatment.I can take care of myself and am up and about more than half of my waking hours.You have a disease that can be measured or observed.You are expected to live for at least 3 more months.
Research Study Groups:
This trial has the following groups:- Group 1: ixazomib, daratumumab, pomalidomide and dexamethasone
Awards:
This trial has 2 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.
- 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.
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