Conditions: Multiple Myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief summary:
This clinical trial is for subjects with multiple myeloma that has returned after treatment (relapsed) or did not respond to prior treatment (refractory). The study is in two parts, Phase I and Phase II. Phase I will determine the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone. The purpose of Phase II is to evaluate the effectiveness of combining romidepsin with pomalidomide and dexamethasone. The hypothesis is that overall response in a cohort of patients treated with romidepsin + pomalidomide + dexamethasone will be 60 percent.

Detailed description:
This phase I/II study is a treatment program for patients with relapsed or refractory multiple myeloma. Up to 48 patients will be enrolled. Phase I will follow a 3+3 dose escalation design to find the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone.

In Phase I, subjects will receive:

* Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
* Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
* Romidepsin intravenously (9 mg/m2, 12 mg/m2, 15 mg/m2 or 18 mg/m2) on days 1 and 15 of a 28-day cycle.

Phase II will expand the number of subjects in the MTD arm of the trial until 48 subjects are enrolled. In Phase II, subjects subjects will receive:

* Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
* Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
* Romidepsin intravenously on days 1 and 15 of a 28-day cycle at the Maximum Tolerated Dose determined by Phase I

Arms:
arm 1: Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined Dexamethasone

Interventions: intervention 1: Romidepsin intervention 2: pomalidomide intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Romidepsin intravenously on days 1 and 15 of a 28-day cycle intervention 2: Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle intervention 3: Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle

Protocol document: