A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 35
- Locations
- 3
- Primary Endpoint
- Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)
Overview
Brief Summary
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop plasma cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may be an effective treatment for primary systemic amyloidosis.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with primary systemic amyloidosis.
Detailed Description
OBJECTIVES:
Primary
* Assess the hematologic response rate in patients with primary systemic amyloidosis treated with lenalidomide, cyclophosphamide, and dexamethasone.
Secondary
- Determine the organ response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the survival of patients treated with this regimen.
OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide* on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients may receive cyclophosphamide for up to 1 year. After completion of study treatment, patients are followed every 6 months for up to 3 years.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
CRD
Lenalidomide 15mg daily (days 1-21)
Cyclophosphamide 300 mg/m^2 (days 1, 8, 15)
Dexamethasone 40 mg weekly
Intervention: cyclophosphamide (Drug)
CRD
Lenalidomide 15mg daily (days 1-21)
Cyclophosphamide 300 mg/m^2 (days 1, 8, 15)
Dexamethasone 40 mg weekly
Intervention: dexamethasone (Drug)
CRD
Lenalidomide 15mg daily (days 1-21)
Cyclophosphamide 300 mg/m^2 (days 1, 8, 15)
Dexamethasone 40 mg weekly
Intervention: lenalidomide (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Achieved a Confirmed Response Defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR)
Time Frame: Duration on study (up to 3 years)
Response that was confirmed on 2 consecutive evaluations during treatment. 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 \<=100 mg per 24 hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
Secondary Outcomes
- Number of Patients With Organ Response(Duration of study (up to 3 years))
- Number of Participants With Severe Adverse Events(Duration of study (up to 3 years))
- Progression Free Survival (PFS)(Duration of study (up to 3 years))
- Overall Survival (OS)(Duration of study (up to 3 years))