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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00477815 |
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Date of registration:
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23/05/2007 |
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Primary sponsor: |
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Public title:
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Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan, Melphalan, and Autologous Peripheral Stem Cell Transplant in Treating Patients With Previously Treated Multiple Myeloma
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Scientific title:
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A Phase I Trial of Zevalin Radioimmunotherapy With High-Dose Melphalan and Stem Cell Transplant for Multiple Myeloma |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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42 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00477815 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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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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Mayo Clinic Clinical Trials Office |
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Address:
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Telephone:
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507-538-7623 |
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Email:
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Affiliation:
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Name:
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Angela Dispenzieri, 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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Mayo Clinic |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
- Previously treated disease
- Candidate for high-dose chemotherapy with melphalan and autologous stem cell
transplantation
- No definite evidence of myelodysplasia on pretreatment bone marrow by morphology or
by chromosome analysis (e.g., monosomy 7)
- Chromosome abnormalities from the myeloma clone allowed
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC = 1,500/mm³
- Platelet count = 100,000/mm³
- Bilirubin = 2.0 mg/dL
- Alkaline phosphatase = 3 times upper limit of normal (ULN)
- AST = 3 times ULN
- Creatinine = 2 times ULN
- LVEF = 45%
- Corrected pulmonary diffusion capacity = 50%
- No uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active malignancy (with the exception of nonmelanoma skin cancer) that
requires myelosuppressive chemotherapy or radiation therapy
- No HIV positivity
PRIOR CONCURRENT THERAPY:
- More than 3 weeks since prior myelosuppressive chemotherapy, except cyclophosphamide
pulsing for stem cell collection)
- No other concurrent immunotherapy, radiotherapy, chemotherapy or antimyeloma therapy
- Concurrent chronic corticosteroids at doses of prednisone = 20 mg per day (or
equivalent) allowed
- Concurrent adjuvant hormonal therapy (e.g., tamoxifen citrate or leuprolide acetate)
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: 111In Zevalin
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Biological: rituximab
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Biological: Sargramostim (GM-CSF)
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Biological: Stem Cell
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Drug: melphalan
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Radiation: 90Y-Zevalin
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Primary Outcome(s)
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Clonotypic B cells
[Time Frame: 19 months]
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Toxicity as measured by CTCAE v 3.0
[Time Frame: 19 Months]
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Secondary Outcome(s)
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Impact of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonal plasma cells in the blood and marrow prior to high-dose melphalan
[Time Frame: 1 week]
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Response (complete response, very good partial response, partial response)
[Time Frame: 19 months]
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Time to progression and duration of response
[Time Frame: 5 years]
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Secondary ID(s)
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021-03-ZEV
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106-P148
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449-05
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CDR0000546732
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MC048A
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NCI-2009-01399
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P30CA015083
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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