NCT00750815

Cyclophosphamide, VELCADE, DOXIL, and Dexamethasone, (CVDD) in Newly Diagnosed Patients With Multiple Myeloma (MM)

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Enroll patients into 4 different dose levels. The dose of Cyclophosphamide they receive will depend on how many patients have been treated.
DRUG	Bortezomib; Pegylated Liposomal Doxorubicin; Dexamethasone (VDD)	Patients will receive Bortezomib, Pegylated Liposomal Doxorubicin and Dexamethasone at standard doses.

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-12-01
• Completion: 2013-05-01
• First posted: 2008-09-11
• Last updated: 2014-01-20
• Results posted: 2014-01-20

Locations

1 site across 1 country: United States