Clinical trial NCT00558896
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma
Sponsor: Mayo Clinic
Start date: 2007-11-01; Completion date: 2017-10-25
Enrollment: 378 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. Dexamethasone and CC-4047 may stop the growth of cancer cells by blocking blood flow to the cancer. Giving CC-4047 together with dexamethasone may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving CC-4047 together with dexamethasone works in treating patients with relapsed or refractory multiple myeloma or amyloidosis.

Detailed description:
OBJECTIVES:

* To assess the response rate and duration of remission with low-dose CC-4047 plus dexamethasone in patients with relapsed or refractory multiple myeloma or amyloidosis.
* To assess the toxicity of CC-4047 plus dexamethasone in this patient population.
* To assess in an expansion cohort the response rate with an increase in CC-4047 dose among patients who fail to respond adequately to the initial starting dose following the first 2 courses of treatment.
* To assess the response rate and duration of remission with CC-4047 plus dexamethasone in patients with lenalidomide resistant or refractory multiple myeloma.
* To assess the response rate and duration of remission with CC-4047 plus dexamethasone in patients with previously treated light chain amyloidosis.
* To assess the response rate and duration of remission with low- and high-dose CC-4047 plus dexamethasone in patients with lenalidomide and bortezomib refractory multiple myeloma.
* To assess the response rate and duration of remission with high-dose CC-4047 plus dexamethasone in patients with relapsed or refractory myeloma who received ≤ 3 treatment regimens.

OUTLINE: Patients are grouped according to disease status (relapsed/refractory myeloma \[closed to accrual as of 8/5/2008\] vs lenalidomide resistant/refractory myeloma \[closed to accrual as of 4/2/2009\] vs previously treated light chain amyloidosis vs lenalidomide and bortezomib resistant/refractory myeloma {low-dose/day}\[closed to accrual as of 11/20/09\] vs lenalidomide and bortezomib resistant/refractory myeloma (high-dose/day) vs relapsed/refractory myeloma {high-dose/day}).

Patients receive oral CC-4047 on days 1-28 and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks and then at 6 months.

Arms: arm 1: Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle

Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle arm 2: Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle

Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle arm 3: Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle

Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle arm 4: Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle

Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle arm 5: Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle

Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle arm 6: Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle

Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle arm 7: Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle

Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
Interventions: intervention 1: dexamethasone intervention 2: pomalidomide
Intervention descriptions: intervention 1: 40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle. intervention 2: 2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).

Protocol documents: