CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Amyloidosis
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): dexamethasone; pomalidomide
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg/day administered through PO (with food) at Days 1, 8, 15, 22 per cycle.; 2 or 4 mg/day administered through PO at days 1 - 28 or days 1-21 (see Arm description for specific dosing).
Other intervention name(s): CC-4047
Intervention MeSH terms: Dexamethasone; Pomalidomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma