Clinical trial · Interventional
CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis
NCT00091260CI-TRIAL-00026047completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- revlimid
- description
- lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
- interventionNames
- Drug: dexamethasone
- Drug: lenalidomide
Primary outcomes (2)
- measure
- Number of Patients Removed From Study Treatment Due to Toxicities
- timeFrame
- 1 year
- measure
- Number of Patients With Hematologic Response With Single-agent CC-5013
- timeFrame
- 3 months
- description
- Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine. For patients with an elevated serum free light chain assay, a reduction of 50% or more.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLichtman EI, Seldin DC, Shelton A, Sanchorawala V. Single agent lenalidomide three times a week induces hematologic responses in AL amyloidosis patients on dialysis. Am J Hematol. 2014 Jul;89(7):706-8. doi: 10.1002/ajh.23722. Epub 2014 Apr 10. PMID 24668858