Cyclophosphamide, VELCADE, DOXIL, and Dexamethasone, (CVDD) in Newly Diagnosed Patients With MM
| Status: | Archived |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2008 |
| End Date: | October 2013 |
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 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. The investigators 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 three subjects enrolled into Phase I of the study will receive dose
level 1. A full safety evaluation will be conducted when these subjects 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 three subjects at a dose
level, that dose level will be considered safe and three subjects will be enrolled at
the next dose level. If 1/3 subjects in a cohort at a dose level has a DLT, the dose
level will be expanded to obtain six evaluable subjects.
- If > 1 of 3 subjects 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 MTD if six patients had been enrolled at that dose level.
Otherwise, expand the immediate lower dose level to six evaluable patients*.
- If there are < 2 subjects with a DLT among the expanded cohort of six evaluable
subjects, a cohort of three subjects will be enrolled in the next higher dose level.
- If there are 2 or more subjects with a DLT among the expanded cohort of six evaluable
subjects, 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 six
patients had been enrolled at that dose level. Otherwise, expand the immediate lower
dose level to six evaluable patients*.
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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