A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis
dexamethasone
+ lenalidomide
Immunoglobulin Light-chain Amyloidosis+15
+ Amyloidosis
+ Blood Protein Disorders
Treatment Study
Summary
Study start date: January 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the tolerability of CC-5013 in patients with primary systemic (AL) amyloidosis. * Determine the objective hematologic response rate in patients treated with this drug. * Determine amyloid organ disease response in patients treated with this drug. Secondary * Determine hematologic and amyloid organ disease response in patients who do not achieve a response to CC-5013 alone and are subsequently treated with CC-5013 and dexamethasone. * Determine the toxicity of CC-5013 in combination with dexamethasone in these patients. OUTLINE: Patients receive oral CC-5013 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response continue to receive CC-5013 as before and also receive oral dexamethasone twice daily on days 1-4, 9-12, and 17-20 of every other 28-day course for up to 6 courses of combination therapy. Patients who maintain a hematologic response after 6 courses of combination therapy may receive CC-5013 alone in the absence of disease progression or unacceptable toxicity. Patients not achieving a hematologic response after the initiation of dexamethasone are removed from the study. Patients are followed annually. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-12.5 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.82 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location