|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00091260 |
|
Date of registration:
|
07/09/2004 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
|
|
Scientific title:
|
A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis |
|
Date of first enrolment:
|
January 2004 |
|
Target sample size:
|
82 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00091260 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
David C. Seldin, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Boston Medical Center |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Multiple Myeloma
|
|
Intervention(s)
|
|
Drug: lenalidomide
|
|
Drug: dexamethasone
|
|
Primary Outcome(s)
|
|
Number of Patients With Hematologic Response With Single-agent CC-5013
[Time Frame: 3 months]
|
|
Number of Patients Removed From Study Treatment Due to Toxicities
[Time Frame: 1 year]
|
|
Secondary Outcome(s)
|
|
Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response
[Time Frame: 1 year]
|
|
Secondary ID(s)
|
|
CDR0000385687
|
|
CELGENE-RV-AMYL-PI-003
|
|
BUMC-H-23235
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|