NCT01212952

Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

MC1082: A Phase I/II Trial of Pomalidomide (CC-4047), Bortezomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Pomalidomide and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pomalidomide and bortezomib together with dexamethasone may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with pomalidomide and dexamethasone and to see how well it works in treating patients with relapsed or refractory multiple myeloma.

Detailed description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of bortezomib in combination with pomalidomide and dexamethasone. II. To evaluate the hematologic response rate (PR, VGPR, or CR) of pomalidomide, bortezomib and dexamethasone in patients with relapsed or refractory myeloma. SECONDARY OBJECTIVES: I. Time to progression. II. To assess the toxicity of pomalidomide, bortezomib and dexamethasone in this patient population. OUTLINE : This is a phase I, dose-escalation study of bortezomib followed by a phase II study. Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8,15, 22; and oral dexamethasone on days 1, 8, 15, 22 . Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.

Conditions

• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	pomalidomide	Given orally
DRUG	bortezomib	Given IV
DRUG	dexamethasone	Given orally
OTHER	laboratory biomarker analysis	Optional correlative studies
OTHER	gene expression analysis	Optional correlative studies

Timeline

• Start date: 2011-09-01
• Primary completion: 2017-08-15
• Completion: 2018-03-22
• First posted: 2010-10-01
• Last updated: 2020-04-17
• Results posted: 2020-04-17

Locations

3 sites across 1 country: United States