NCT03256045

Panobinostat, Carfilzomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

CLBH589DUS108T: Panobinostat With Carfilzomib and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Correlation With In Vitro Chemosensitivity Testing

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well panobinostat, carfilzomib, and dexamethasone work in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carfilzomib and 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. Using multiple myeloma cells from patients' blood samples, the researchers will do laboratory tests to look at how well each of the drugs, alone and in different combinations, kill multiple myeloma cells. If the laboratory tests work well, they may be used in the future to help plan treatment for future patients.

Detailed description

PRIMARY OBJECTIVE: I. To correlate in vitro drug sensitivity testing with clinical response by determining the rate of in vitro drug sensitivity to panobinostat, carfilzomib, and dexamethasone singly and in combination, doublets and triplets. SECONDARY OBJECTIVE: I. To monitor response rates (partial response \[PR\], very good partial response \[VGPR\], and complete response) using the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. EXPLORATORY OBJECTIVE: I. Progression free survival and overall survival will be assessed for up to 3 years after last dose. OUTLINE: Patients receive panobinostat orally (PO) on days 1, 3, 5, 15, 17, and 19. Patients also receive carfilzomib intravenously (IV) and dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and/or bone marrow samples for testing via in vitro chemosensitivity assay. After completion of study treatment, patients are followed up every 3 months for up to 3 years.

Conditions

• Recurrent Plasma Cell Myeloma
• Refractory Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib	Given IV
OTHER	Chemosensitivity Assay	Undergo in vitro chemosensitivity testing
DRUG	Dexamethasone	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Panobinostat	Given PO

Timeline

• Start date: 2018-02-08
• Primary completion: 2021-02-05
• Completion: 2021-02-05
• First posted: 2017-08-21
• Last updated: 2022-05-09
• Results posted: 2022-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study