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Proteasome Inhibitor

Carfilzomib + Lenalidomide + Vorinostat + 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

Must not have

Concurrent use of histone deacetylase inhibitor (eg. Valproic acid)

Use of any other experimental drug or therapy within 28 days of baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of the last administration of study treatment

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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My multiple myeloma has returned or didn't respond after my first treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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I have symptoms from my multiple myeloma.

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I agree to use a latex condom during sex with a female capable of becoming pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking a medication like Valproic acid.

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I haven't used any experimental drugs or therapies in the last 28 days.

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I do not have any mental health or medical conditions that could affect my treatment.

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I haven't taken high doses of steroids like dexamethasone or prednisone in the last 3 weeks.

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I do not have HIV or active hepatitis A, B, or C.

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I haven't needed strong infection treatments in the last week.

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I need regular procedures to remove fluid from my chest or abdomen.

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I have been diagnosed with POEMS syndrome.

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I have been diagnosed with Waldenström's macroglobulinemia.

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I haven't had cancer treatment or steroids in the last 2 weeks.

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I haven't had radiation in the last week or immunotherapy in the last 3 weeks.

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I haven't been in a drug study within the last 3 weeks or 5 drug half-lives.

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I have not had major surgery in the last 2 weeks.

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I do not have severe heart failure or recent heart attacks.

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My high blood pressure is not under control.

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I cannot undergo the required hydration program due to existing heart, lung, or kidney issues.

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I cannot take certain medications like aspirin, antivirals, or blood thinners due to past reactions or conditions.

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My multiple myeloma does not produce high levels of antibodies.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of the last administration of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and dose of carfilzomib, lenalidomide, vorinostat and dexamethasone for MM

Secondary study objectives

Overall response rate (ORR) Time to next treatment (TTNT) Time to progression (TTP) Duration of response (DOR

Awards & Highlights

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.

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.

0 / 24Eligibility criteria met