NCT01432600

Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide

Evaluation of Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide in Patients With Relapsed and Refractory Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to see whether pomalidomide can help people with myeloma. Researchers also want to find out if pomalidomide is safe and tolerable.

Detailed description

There are two parts to this study: * Phase 1: To determine a safe dose of the medication cyclophosphamide in combination with pomalidomide and dexamethasone. * Phase 2: To see the difference in effectiveness of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide for the treatment of participants who have myeloma, which has relapsed to or become refractory (not responding) to prior treatment.

Conditions

• Myeloma

Interventions

Type	Name	Description
DRUG	Pomalidomide	Pomalidomide at 4 mg by mouth (PO) as outlined in the treatment arms.
DRUG	Dexamethasone	Dexamethasone at 40 mg (20 mg) PO as outlined in the treatment arms.
DRUG	Cyclophosphamide	The dose escalation uses a standard "3x3" design: Ex: If none of the first 3 participants have a DLT, enter 3 participants at the next higher dose level. Once the maximum tolerated dose (MTD) of oral weekly cyclophosphamide in combination with pomalidomide and dexamethasone was determined, investigators proceeded with the second phase of the trial, a randomized phase II study comparing pomalidomide and dexamethasone with pomalidomide, dexamethasone and oral weekly cyclophosphamide delivered at the MTD determined in the phase I study.

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2011-09-13
• Last updated: 2017-05-23
• Results posted: 2017-05-23

Locations

3 sites across 1 country: United States