Last updated: November 7, 2021
Sponsor: Masonic Cancer Center, University of Minnesota
Overall Status: Completed
Phase
2/3
Condition
Multiple Myeloma
Leukemia
Lymphoproliferative Disorders
Treatment
N/AClinical Study ID
NCT00177047
2004LS001
MT2003-13
0312M54569
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients meeting the Durie and Salmon criteria for initial diagnosis of multiplemyeloma, requiring therapy and meeting one of the following:
- After initial therapy in either first complete or partial remission or noobjective response
- After achieving initial response and later disease progression, patient will beeligible after subsequent therapy upon achievement of either complete or partialresponse
- Is not eligible or has refused any protocols of higher priority
- 18 - 75 years of age
- Adequate organ function defined as:
- Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused)
- Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGAscan
- Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal
- Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted
- Performance status: Karnofsky performance of > 80%.
- Free of active uncontrolled infection at the time of study entry.
- At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.
- Patients must exercise informed voluntary consent and sign a consent form approved bythe University of Minnesota IRB: Human Subjects Committee.
Exclusion
Exclusion Criteria:
- Patients will be ineligible if they have advanced myeloma refractory and unresponsiveto salvage chemotherapy regimens.
- Female patients who are pregnant (positive b-HCG) or breastfeeding will be excludedfrom study entry. In addition fertile men or women unwilling to use contraceptivetechniques during and for 12 months following treatment, particularly afterthalidomide will also be excluded from study entry.
Study Design
Total Participants: 363
Study Start date:
April 20, 2004
Estimated Completion Date:
August 01, 2020
Study Description
Connect with a study center
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
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