CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Interventions
- Registration Number
- NCT00558896
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 378
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lenalidomide Refractory Myeloma dexamethasone 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 Bortezomib/Lenalidomide Refractory/Relapsed Myeloma dexamethasone 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 Lenalidomide Refractory Myeloma pomalidomide 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 Relapsed Myeloma (< 4 Prior Regimens) pomalidomide 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 Relapsed Amyloidosis pomalidomide 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 Relapsed Myeloma (<4 Prior Regimens) pomalidomide 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 Relapsed Myeloma (<4 Prior Regimens) dexamethasone 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 Bortezomib/Lenalidomide Refractory/Relapsed Myeloma pomalidomide 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 Bortezomib/Lenalidomide Relapsed/Refractory Myeloma pomalidomide 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 Bortezomib/Lenalidomide Relapsed/Refractory Myeloma dexamethasone 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 Relapsed Myeloma (< 4 Prior Regimens) dexamethasone 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 Relapsed/Refractory Myeloma dexamethasone 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 Relapsed/Refractory Myeloma pomalidomide 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 Relapsed Amyloidosis dexamethasone 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
- Primary Outcome Measures
Name Time Method The Number of Confirmed Hematologic Responses (Complete, Partial, or Very Good Partial Response) Duration of study (up to 3 years) Response that was confirmed on 2 consecutive evaluations
* Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow.
* Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours; \<=5% plasma cells in bone marrow.
* Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Duration of study (up to 5 years) PFS was defined as the time from registration to progression or death due to any cause. PFS was analyzed using Kaplan Meier method.
Progression was defined as any one or more of the following:
* 25% increase in serum M-component (absolute increase \>= 0.5g/dl)
* 25% increase in urine M-component (absolute increase \>= 200mg/24hour
* 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl)
* 25% increase in bone marrow plasma cell percentage (absolute increase of \>=10%)
* Definite development of new bone lesion or soft tissue plasmacytomasDuration of Response Duration of study (up to 5 years) Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome.
Trial Locations
- Locations (3)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States