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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00007995 |
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Date of registration:
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06/01/2001 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis
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Scientific title:
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Phase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain Amyloidosis |
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Date of first enrolment:
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July 1999 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00007995 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Charles S. Hesdorffer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Herbert Irving Comprehensive Cancer Center |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed multiple myeloma OR
- Primary systemic amyloidosis resulting in significant organ dysfunction and decreased
quality of life
- Complete or partial response after standard chemotherapy
- Primary refractory or relapsed multiple myeloma after first-line treatment with
standard chemotherapy
- Ineligible for higher priority national or institutional clinical studies
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 2 times normal
Renal:
- Creatinine less than 2.5 mg/dL or on stable hemodialysis
Cardiovascular:
- LVEF at least 45%
Pulmonary:
- DLCO at least 60% of predicted OR
- Approval by pulmonologist
Other:
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Concurrent participation in gene therapy trials allowed
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent steroids as antiemetics during chemotherapy
- No concurrent anticancer hormonal therapy
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent barbiturates or acetaminophen during chemotherapy
- Concurrent participation in supportive care trials allowed
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma and Plasma Cell Neoplasm
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Intervention(s)
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Biological: filgrastim
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Procedure: peripheral blood stem cell transplantation
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Drug: busulfan
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Biological: sargramostim
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Drug: cyclophosphamide
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Procedure: autologous bone marrow transplantation
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Drug: melphalan
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Biological: recombinant interferon alfa
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Procedure: bone marrow ablation with stem cell support
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Primary Outcome(s)
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Disease-free survival at 2 years (patients with responsive disease)
[Time Frame: No]
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Secondary Outcome(s)
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Platelet independence
[Time Frame: No]
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Duration of hematologic toxicity
[Time Frame: Yes]
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Time to an absolute neutrophil count
[Time Frame: No]
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Secondary ID(s)
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CPMC-CAMP-009
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CPMC-IRB-7328
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NCI-G00-1882
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CDR0000068361
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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