Phase 2
N=16
Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00679367 ↗Enrolled (actual)
16
Serious AEs
100.0%
Results posted
Feb 2017
Primary outcome: Primary: Number of Participants With Hematologic Response — 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dexamethasone (Drug); lenalidomide (Drug); melphalan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hematologic Response |
7 | — |
| SECONDARY Number of Organs Improved or Stable Based on Description Below: |
10 | — |
| SECONDARY Number of Participants Removed From Study Due to Toxicities |
6 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis.
PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
Eligibility Criteria
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of primary systemic amyloidosis
PATIENT CHARACTERISTICS:
- Not pregnant
- Negative pregnancy test
- Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day, therapeutic warfarin, or low molecular weight heparin)
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- Permanent or stable side effects/changes allowed
- Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed
- More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or radiotherapy
Exclusion Criteria
- No secondary or familial amyloidosis
- No multiple myeloma (≥ 30% plasma cells in bone marrow biopsy or lytic bone lesions)
- No prior cumulative doses of oral melphalan > 200 mg
- No more than one prior course of high-dose melphalan with stem cell transplant
Data sourced from ClinicalTrials.gov (NCT00679367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.