Multiple Myeloma Clinical Trial
Official title:
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
Cyclophosphamide is a chemotherapy agent with known activity in myeloma. The new regimen
that we will test in this study is called CVDD and contains Cyclophosphamide with Bortezomib
(VELCADE), Pegylated Liposomal Doxorubicin (DOXIL®, PLD), and Dexamethasone (VDD).
The purpose of this study is to determine if the addition of another type of chemotherapy
agent, Cyclophosphamide, to the regimen VDD (CVDD) is well tolerated and improves response
rates in myeloma. We will also find the highest safe dose of the study drugs taken together
that a patient can tolerate, and how long it takes for multiple myeloma patients to respond
after they have taken the study drugs and how long the response lasts.
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
follows:
- 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 planned dose (MPD) if 6 patients had been
enrolled at that dose level. Otherwise, expand the immediate lower dose level to 6
evaluable patients*.
- 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
level.
- 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 MPD 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 MPD. Otherwise, the dose will be further de-escalated in a
similar fashion until the MPD is reached.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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