NCT02095834

Carfilzomib, Bendamustine Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Single Center Phase Ib Study of Carfilzomib, Bendamustine, and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib trial studies the side effects and best doses of carfilzomib and bendamustine hydrochloride when given together with dexamethasone in treating patients with multiple myeloma that has returned or does not respond to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work to stop the growth of cancer cells by killing the cells. Biological therapies, such as dexamethasone, may stimulate the immune system and stop cancer cells from growing. Giving carfilzomib, bendamustine hydrochloride, and dexamethasone may be a better way to treat multiple myeloma.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of carfilzomib in combination with bendamustine (bendamustine hydrochloride) and dexamethasone, up to a maximum bendamustine dose of 90 mg/m\^2. SECONDARY OBJECTIVES: I. To evaluate the safety of carfilzomib in combination with bendamustine and dexamethasone, at the MTD. II. To evaluate the response rate and duration of response of carfilzomib in combination with bendamustine and dexamethasone, in patients with relapsed and or refractory multiple myeloma. OUTLINE: This is a dose-escalation study of carfilzomib and bendamustine hydrochloride. Patients receive dexamethasone orally (PO) or intravenously (IV) over 20 minutes on days 1, 2, 8, 9, 15, 16, 22, and 23 of courses 1-3; on days 1, 2, 15, and 16 of courses 4-12; and on days 1 and 2 of all subsequent courses. Patients also receive bendamustine hydrochloride IV over 10 minutes on days 1 and 2 of courses 1-3 and on day 1 of all subsequent courses and carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16 of courses 1-12 and on days 1, 2, 15, and 16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days, every 3 months for 1 year, and then every 6 months thereafter.

Conditions

• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Bendamustine Hydrochloride	Given IV
DRUG	Carfilzomib	Given IV
DRUG	Dexamethasone	Given PO or IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2014-04-24
• Primary completion: 2021-01-07
• Completion: 2021-01-07
• First posted: 2014-03-26
• Last updated: 2021-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study