An Open-Label Phase 1/2 Study of VELCADE for Injection in Subjects With Light-Chain (AL)-Amyloidosis
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
Maximum Tolerated Dose (MTD) was defined as the highest dose level that has 0/1 out of 6 patients experiences Dose Limited Toxicity (DLT). MTD is defined separately for QW and BIQ dose cohorts. DLT was defined as adverse events occurring during Cycle 1 and: (1) related to VELCADE, (2) Grade 4 thrombocytopenia or neutropenia, (3) Grade 3 or higher nonhematologic toxicity.
5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts
Millennium Pharmaceuticals, Inc.
United States: Food and Drug Administration
|Boston Medical Center||Boston, Massachusetts 02118|
|Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute||Los Angeles, California 90049|
|Winship Cancer Center - Emory Clinic School of Medicine||Atlanta, Georgia 30322|
|MSKCC||New York, New York 10017|