Telaglenastat + Carfilzomib + Dexamethasone for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Wilson Gonsalves, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the best dose of CB-839 HCl when given together with carfilzomib and dexamethasone in treating patients with multiple myeloma that has come back or does not respond to previous treatment. CB-839 HCl and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CB-839 HCl, carfilzomib, and dexamethasone may work better in treating patients with multiple myeloma.

Eligibility Criteria

This trial is for adults with multiple myeloma that has returned or isn't responding to treatment. They must have had at least two prior treatments, including a proteasome inhibitor and an immunomodulatory drug. Participants need adequate blood counts, organ function, and agree to use effective contraception. Those who can't join include those intolerant to carfilzomib, on other trials, with uncontrolled illnesses, pregnant or nursing women, and those with certain medical conditions.

Inclusion Criteria

I am willing to have a bone marrow test during the study.

Ability to understand and the willingness to sign a written informed consent document

Your hemoglobin level is at least 8 grams per deciliter within 14 days before joining the study.

Exclusion Criteria

I have a stomach or intestine condition that affects how I absorb pills.

I cannot tolerate or did not respond to carfilzomib treatment.

My cancer has spread to my brain or spinal cord.

Treatment Details

Interventions

• Carfilzomib (Proteasome Inhibitor)
• CB-839 HCl (Enzyme Inhibitor)
• Dexamethasone (Corticosteroid)

Trial Overview The trial tests the best dose of CB-839 HCl combined with carfilzomib and dexamethasone in patients whose multiple myeloma has relapsed or is refractory. The goal is to find out if this combination can better halt cancer growth by blocking enzymes needed for cell growth compared to current treatments.

Participant Groups

Group I: Treatment (CB-839 HCI, dexamethasone, carfilzomib) Experimental Treatment 3 Interventions

Patients receive glutaminase inhibitor CB-839 Patients receive glutaminase inhibitor CB-839 hydrochloride PO every 12 hours on days 1-28, dexamethasone PO on days 1, 2, 8, 9, 15, 16, and 23, and carfilzomib IV over 10 minutes on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity

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

🇺🇸 Approved in United States as Kyprolis for:

• Multiple myeloma

🇪🇺 Approved in European Union as Kyprolis for:

• Multiple myeloma

🇨🇦 Approved in Canada as Kyprolis for:

• Multiple myeloma

🇯🇵 Approved in Japan as Kyprolis for:

• Multiple myeloma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Moffitt Cancer Center Tampa, FL

Mayo Clinic in Rochester Rochester, MN

Ohio State University Comprehensive Cancer Center Columbus, OH

Rutgers Cancer Institute of New Jersey New Brunswick, NJ

More Trial Locations

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References