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Trial: NCT00003195 [RDF]

Label NCT00003195
Slug nct00003195
Trialid NCT00003195
Lookup name NCT00003195
Provenance http://clinicaltrials.gov/show/NCT00003195?displayxml=true
Lastchanged date November 15, 2011
Firstreceived results date
Firstreceived date November 1, 1999
Id info nct id NCT00003195
Overall status Completed
Id info secondary id FHCRC-1272.00
Biospec retention
Required header link text Link to the current ClinicalTrials.gov record.
Enrollment
Number of arms
Is section 801
Is fda regulated
Brief title Total-Body Irradiation, Busulfan, and Interferon Alfa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Multiple Myeloma
Acronym
Official title A Phase II Study of Total Marrow Irradiation, Busulfan, and Alpha-Interferon Followed by Allogeneic Peripheral Blood Stem Cell or Marrow Transplantation for Treatment of Patients With Advanced Multiple Myeloma.
Study type Interventional
Id info nct alias
Completion date November 2000
Verification date November 2011
Why stopped
Id info org study id 1272.00
Required header url https://clinicaltrials.gov/show/NCT00003195
Study design Primary Purpose: Treatment
Source Fred Hutchinson Cancer Research Center
Primary completion date
Brief summary
Number of groups
Required header download date ClinicalTrials.gov processed this data on September 08, 2016
Phase Phase 2
Start date December 1997
Has expanded access No
Biospec descr
Detailed description OBJECTIVES: I. Evaluate the effects of total marrow irradiation and busulfan followed by allogeneic peripheral blood stem cell or marrow transplantation on the outcomes of treatment related mortality, response, relapse, survival, and event free survival for patients with advanced multiple myeloma. OUTLINE: Peripheral blood stem cell (PBSC) or bone marrow (BM) collection and infusion are performed according to standard practice. Patients undergo total marrow irradiation (TMI) bid for 3 days. Busulfan is administered every 6 hours on days -6 to -3. PBSC or BM is infused on day 0. Interferon alfa is administered subcutaneously on Mondays, Wednesdays, and Fridays beginning on day 80. Interferon therapy may continue in the absence of graft versus host disease or disease progression. Patients are followed on days 56 and 84, then every 6 months for 2 years, and annually thereafter. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued over 3 years.
Condition browse 6356e82c935484cc87a0d648790c5c27
Intervention browse 8ae0e3d50cdb58334190882fddbd94d1
Responsible party None
Overall contact None
Overall contact backup None
Sponsor group f740aa1da4e0bea9987a3e911973e253
Oversight info United States: Federal Government (Oversight_info)
Eligibility 64dbc86c5acbfd7bdc2684ba98ae43c1
Keywords refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Conditions Multiple Myeloma and Plasma Cell Neoplasm
Locations 31dfd9fd7c5ace212e8a9e5e78c6d9e0
Links None
Results references None
Arm groups None
Location countries United States
Interventions recombinant interferon alfa (Intervention), radiation therapy (Intervention), peripheral blood stem cell transplantation (Intervention), busulfan (Intervention), allogeneic bone marrow transplantation (Intervention)
Secondary outcomes None
References None
Primary outcomes None
Removed countries None
Overall officials bbce80b3ea0aaf1b0731f8e035fb7ab6