Conditions: Multiple Myeloma in Relapse
Keywords: myeloma relapse refractory relapsed pomalidomide pomalyst everolimus afinitor dexamethasone
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief summary:
This study is being conducted to test the possibility that a combination of three drugs, pomalidomide and everolimus with dexamethasone, may improve patient responses when compared with use of either drug alone, with dexamethasone in refractory/relapsed multiple myeloma.

Detailed description:
Given that pomalidomide is an FDA approved drug for patients with relapsed or progressive myeloma, and everolimus has been shown to have single agent activity in relapsed myeloma, it seems reasonable to combine these two active drugs in patients with relapsed/refractory disease. Given that low dose dexamethasone dramatically improved the response rate of pomalidomide, this drug will be added to the combination.

Arms:
arm 1: Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle

Interventions: intervention 1: Combination therapy
Intervention descriptions: intervention 1: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.

Cycles will span 28 days. Dosage schedules will be:

1. Everolimus daily for 28 days of a 28 day cycle;
2. Pomalidomide daily for 21 days of a 28 day cycle
3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.

Protocol document: