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Proteasome Inhibitor
Vorinostat, Lenalidomide, Carfilzomib, Dexamethasone for Multiple Myeloma (QUAD Trial)
Phase 1 & 2
Waitlist Available
Led By David Siegel, MD, PhD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Laboratory: Adequate hepatic function, with bilirubin < 2 times the upper limit of normal
Females of Child Bearing Potential* (FCBP) must have a negative serum or urine pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of the last administration of study treatment
Awards & highlights
QUAD Trial Summary
This trial will test a combination of 4 drugs to treat multiple myeloma and see if it is effective.
Who is the study for?
Adults with symptomatic multiple myeloma who have relapsed or are refractory after at least one treatment can join. They must have measurable disease, adequate organ function, and a life expectancy over three months. Women of childbearing age must test negative for pregnancy and use two forms of birth control; men must use condoms.Check my eligibility
What is being tested?
The trial is testing the combination of Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone in patients with multiple myeloma that has come back or hasn't responded to treatment. It aims to see if these four drugs work better together.See study design
What are the potential side effects?
Potential side effects include blood disorders (like low platelet count), liver issues (elevated bilirubin levels), kidney problems (reduced creatinine clearance), heart complications like congestive heart failure or recent myocardial infarction, infections requiring IV antibiotics, and significant neuropathy.
QUAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is functioning well, with normal bilirubin levels.
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I am capable of becoming pregnant and have a negative pregnancy test.
Select...
My multiple myeloma has returned or didn't respond after my first treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have symptoms from my multiple myeloma.
Select...
I agree to use a latex condom during sex with a female capable of becoming pregnant.
QUAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days of the last administration of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of the last administration 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
Safety and dose of carfilzomib, lenalidomide, vorinostat and dexamethasone for MM
Secondary outcome measures
Overall response rate (ORR) Time to next treatment (TTNT) Time to progression (TTP) Duration of response (DOR
QUAD Trial Design
1Treatment groups
Experimental Treatment
Group I: carfilzomib for MMLExperimental Treatment1 Intervention
Vorinostat, Lenalidomide, Carfilzomib, Dexamethasone - This study will be conducted as an open-label Phase I/II, single-center study in which subjects will receive carfilzomib, lenalidomide, vorinostat and dexamethasone, for relapsed and/or refractory multiple myeloma. Study treatment will be administered in sequential cohorts, with 3-6 subjects in each cohort. Treatment will be administered in 28-day cycles, with the fourth week as a rest week, for 12 cycles or until disease progression or unacceptable toxicity develops.
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,210 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,403 Patients Enrolled for Multiple Myeloma
David Siegel, MD, PhDPrincipal InvestigatorHackensack Meridian Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can follow the study's schedule and visit the institute for treatment and tests.My liver is functioning well, with normal bilirubin levels.I agree to take aspirin daily or use anticoagulants if I'm allergic or have had blood clots.I am currently taking a medication like Valproic acid.I haven't used any experimental drugs or therapies in the last 28 days.I do not have any mental health or medical conditions that could affect my treatment.I haven't taken high doses of steroids like dexamethasone or prednisone in the last 3 weeks.I do not have HIV or active hepatitis A, B, or C.I haven't needed strong infection treatments in the last week.I need regular procedures to remove fluid from my chest or abdomen.I have been diagnosed with POEMS syndrome.I have been diagnosed with Waldenström's macroglobulinemia.I haven't had cancer treatment or steroids in the last 2 weeks.I am 18 years old or older.I am capable of becoming pregnant and have a negative pregnancy test.I haven't had radiation in the last week or immunotherapy in the last 3 weeks.I haven't been in a drug study within the last 3 weeks or 5 drug half-lives.I do not have severe nerve pain or damage.I cannot take certain medications like aspirin, antivirals, or blood thinners due to past reactions or conditions.I have not had major surgery in the last 2 weeks.I can take care of myself and am up and about more than half of my waking hours.I cannot undergo the required hydration program due to existing heart, lung, or kidney issues.I do not have severe heart failure or recent heart attacks.My high blood pressure is not under control.My multiple myeloma has returned or didn't respond after my first treatment.I have symptoms from my multiple myeloma.My multiple myeloma does not produce high levels of antibodies.I agree to use a latex condom during sex with a female capable of becoming pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: carfilzomib for MML
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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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