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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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4 March 2013 |
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Main ID: |
NCT00006244 |
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Date of registration:
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11/09/2000 |
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Primary sponsor: |
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Public title:
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Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma
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Scientific title:
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Immunotherapy for Autologous/Syngeneic Peripheral Blood Stem Cell (PBSC) Transplant Patients as Treatment for Advanced Multiple Myeloma |
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Date of first enrolment:
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February 2000 |
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Target sample size:
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40 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00006244 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, 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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Leona Holmberg |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient must be less than 70 years old
- Patients with advanced Multiple Myeloma that meet the eligibility requirements for
mobilization/debulking with Cytoxan/VP-16/G-CSF, Cytoxan/Taxol/G-CSF, or
Cytoxan/G-CSF (according to protocol 506.03); if clinically indicated a lower dose of
cytoxan than 4g/m2 may be used for mobilization based on the attending's discretion;
also, if the patients had previously collected PBSC of sufficient number in the past
and meet the other eligibility requirements, they may be entered on this study after
approval by the PI
- Patients with advanced Multiple Myeloma that have an identical syngeneic twin for
donation of PBSCs
- Patients have advanced Multiple Myeloma if they were diagnosed initially with stage
II or III disease or had stage I disease that progressed after initial therapy or
failed to respond to therapy
- Syngeneic Donor Inclusion:
- Donor and patient have adequate documentation that donor and recipient are
syngeneic; including ABO typing, HLA typing and VNTR studies
- Donor > 20 kg
- Donor meets eligibility to donate according to Standard Practice Guidelines
Exclusion Criteria:
- Patient's age >= 70
- Karnofsky score less than 80
- A left ventricular ejection fraction less than 50%; Patients with congestive heart
disease, history of myocardial infarction (MI), coronary artery disease or any
arrhythmia history
- Total bilirubin > 1.5 mg/ml (unless history of Gilbert's disease)
- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase
(SGPT) > 2 x upper limit of normal
- Estimated creatinine clearance < 60 ml/min or creatinine serum > 2.0 mg/dl
- Pregnancy
- Seropositivity for human immunodeficiency virus
- Patients who cannot give informed consent
- Secondary malignancies other than basal cell carcinoma of the skin or carcinoma in
situ within the last five years
- History of seizures or requirement for medicines, such as haldol, for controlling
mental disorders
- Concurrent need for corticosteroid therapy
- Active connective tissue disease
- Pleural effusion, pericardial effusion or ascites
- Patients allergic to gentamicin
- Patients with positive PCR for hepatitis C or hepatitis B
- Patients with hypersensitivity to E. coli - derived preparations
- Patients with systemic infection at time of IL2 therapy
- Patients who previously have had more than 50% of their pelvic area irradiated
- Patients with pulmonary function tests that show diffusion capacity (corrected) <
60%, and/or forced expiratory volume in 1 second (FEV1) < 65% of predicted
Age minimum:
18 Years
Age maximum:
69 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Refractory Multiple Myeloma
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Stage I Multiple Myeloma
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Stage II Multiple Myeloma
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Stage III Multiple Myeloma
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Intervention(s)
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Biological: aldesleukin
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Biological: recombinant interferon alfa
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Drug: melphalan
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Procedure: in vitro-treated peripheral blood stem cell transplantation
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Primary Outcome(s)
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Initial response to therapy (complete response, partial response, or progression of disease)
[Time Frame: 2 years]
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Overall survival
[Time Frame: From baseline until disease progression, assessed up to 50 years]
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Time to disease progression
[Time Frame: From baseline until disease progression, assessed up to 50 years]
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Secondary Outcome(s)
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Number of patients experiencing grade 3-4 regimen related toxicity
[Time Frame: From baseline until disease progression, assessed up to 50 years]
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Secondary ID(s)
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1461.00
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NCI-2011-01313
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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