Phase 2
N=82
CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00091260 ↗Enrolled (actual)
82
Serious AEs
100.0%
Results posted
Feb 2017
Primary outcome: Primary: Number of Patients Removed From Study Treatment Due to Toxicities — 31 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- dexamethasone (Drug); lenalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vaishali Sanchorawala
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Removed From Study Treatment Due to Toxicities |
31 | — |
| PRIMARY Number of Patients With Hematologic Response With Single-agent CC-5013 |
5 | — |
| SECONDARY Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response |
26 | — |
Summary
RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis.
PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.
Eligibility Criteria
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary systemic (AL) amyloidosis
- Tissue amyloid deposits or positive fat aspirate
- Meets 1 of the following criteria for AL type disease:
- Serum or urine monoclonal protein by immunofixation electrophoresis
- Plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light chain isotype
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- SWOG 0-2
Life expectancy
- Not specified
Hematopoietic
- White blood count> 3,000/mm^3
- Hemoglobin > 8 g/dL
- Platelet count > 100,000/mm^3
- Absolute neutrophil count > 1,000/mm^3
Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior thalidomide for AL amyloidosis allowed
Chemotherapy
- More than 4 weeks since prior cytotoxic chemotherapy
Endocrine therapy
- Prior steroids for AL amyloidosis allowed
Radiotherapy
- More than 4 weeks since prior radiotherapy
Surgery
- Prior surgery allowed
Other
- Recovered from all prior therapy
Exclusion Criteria
- No secondary or familial amyloidosis
- No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR lytic bone lesions
- No prior CC-5013
Renal
- No dialysis
Cardiovascular
- No symptomatic cardiac arrhythmia
- No oxygen-dependent restrictive cardiomyopathy
Other
- No untreated or uncontrolled infection
- No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix or breast
- No other serious medical illness that would preclude study participation
- No history of hypersensitivity reaction to thalidomide
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Data sourced from ClinicalTrials.gov (NCT00091260). 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.