An Open Label Phase I/II Study of the Safety and Efficacy of Cyclophosphamide, Bortezomib (VELCADE), Pegylated Liposomal Doxorubicin (DOXIL), and Dexamethasone, (CVDD) in Newly Diagnosed Patients With Multiple Myeloma
The first cohort of 3 participants enrolled into Phase I of the study will receive dose
level 1. A full safety evaluation will be conducted when these participants have completed
one cycle (21 days) of combination therapy. Further patient accrual will be suspended while
the safety data is evaluated at each dose level.
Dose escalation for subsequent patients will proceed through dose levels 2, 3 and 4 as
- If no dose limiting toxicity (DLT) is reported in the first 3 participants at a dose
level, that dose level will be considered safe and 3 participants will be enrolled at
the next dose level. If 1/3 participants in a cohort at a dose level has a DLT, the
dose level will be expanded to obtain 6 evaluable participants.
- If > 1 of 3 participants in a cohort experience DLT, that dose level will not be
considered safe. No further dose escalation will take place, and the immediate lower
dose level will be considered the maximum tolerated dose (MTD) if 6 patients had been
enrolled at that dose level. Otherwise, expand the immediate lower dose level to 6
- If there are < 2 participants with a DLT among the expanded cohort of 6 evaluable
participants, a cohort of 3 participants will be enrolled in the next higher dose
- If there are 2 or more participants with a DLT among the expanded cohort of 6 evaluable
participants, that dose level will not be considered safe. No further dose escalation
will take place, and the immediate lower dose level will be considered the MTD if 6
patients had been enrolled at that dose level. Otherwise, expand the immediate lower
dose level to 6 evaluable patients*.
- * If DLT occurs in no more than 1 patient in the expanded dose cohort, then that dose
level will be considered MTD. Otherwise, the dose will be further de-escalated in a
similar fashion until the MTD is reached.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I - Maximum Tolerated Dose (MTD)
The primary objective of this phase is to determine the maximum tolerated dose of cyclophosphamide when given in combination with VELCADE, DOXIL and Dexamethasone (CVDD) in patients with newly diagnosed active multiple myeloma.
12 months from last enrollment date
Melissa Alsina, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|