NCT00091260 · REGISTRY CONDITION SEARCH

CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2017-02-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients Removed From Study Treatment Due to Toxicities

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outcome · POSTED

Number of Patients With Hematologic Response With Single-agent CC-5013

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outcome · POSTED

Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: dexamethasone
Drug: lenalidomide
label
revlimid
type
EXPERIMENTAL

interventions

arm Group Labels
revlimid
description
dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.
name
dexamethasone
other Names
dexamethasone acetate
type
DRUG
arm Group Labels
revlimid
description
15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone
name
lenalidomide
other Names
revlimid; CC-5013
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 82
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Number of Patients Removed From Study Treatment Due to Toxicities
time Frame
1 year
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.
measure
Number of Patients With Hematologic Response With Single-agent CC-5013
time Frame
3 months

secondary Outcomes

measure
Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response
time Frame
1 year

Full study description

brief 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.
detailed Description: 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.

Source references

references

citation
Lichtman 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
type
DERIVED

Source notices and limitations

Discovery and provenance

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source url
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Preserved source evidence · Not medical advice