Carfilzomib + Lenalidomide + Vorinostat + Dexamethasone for Multiple Myeloma (QUAD Trial)

Recruiting in Palo Alto (17 mi)

Siegel, M.D., Ph.D in Hackensack, NJ ...

Overseen ByDavid S Siegel

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Hackensack Meridian Health

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will evaluate the feasibility of combining four of the most active agents available for the treatment of multiple myeloma. Further the investigators will attempt to assess the activity of this combination.

Eligibility Criteria

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.

Inclusion Criteria

My liver is functioning well, with normal bilirubin levels.

I am capable of becoming pregnant and have a negative pregnancy test.

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

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

I have symptoms from my multiple myeloma.

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

Exclusion Criteria

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 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 have not had major surgery in the last 2 weeks.

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

My high blood pressure is not under control.

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

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

My multiple myeloma does not produce high levels of antibodies.

Participant Groups

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.

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.

Carfilzomib is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Kyprolis for: