A Study to Evaluate the Use of Chloroquine in Combination With VELCADE and Cyclophosphamide in Patients With Relapsed and Refractory Multiple Myeloma
Patients with myeloma that has either not responded to previous treatment or has returned after previous treatment will be given a combination of the drugs chloroquine, cyclophosphamide and bortezomib.
VELCADE will be given intravenously on days 1, 4, 8, 11, 22, 25, 29 and 32. Cyclophosphamide will be given orally 2x/day and Chloroquine orally daily both on days 1-14 and 22-35. 14 patients will be treated with this regimen. Each cycle will be 42 days in length. Patients will receive the study drugs until their disease progresses or they are withdrawn from the study.
In other studies, Velcade seems to work well with other drugs. Thus, this study hopes to show that the combination of Cyclophosphamide and Chloroquine, will have activity in relapsed/refractory myeloma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Trial of Chloroquine in Combination With VELCADE and Cyclophosphamide in Patients With Relapsed and Refractory Myeloma|
- Response rate (CR + PR after 2 cycles) [ Time Frame: after 84 days ] [ Designated as safety issue: No ]each cycle is 42 days long
- Number of participants with adverse events of grade 3 or higher (based on CTCAE 4.0 scale) [ Time Frame: days 1, 4, 8, 11, 15, 22, 25, 29, 32, 36 of each 42 day cycle ] [ Designated as safety issue: Yes ]toxicity will be assessed and graded by severity on these specified days, as the patient will come to clinic on these days. However, patients may contact the clinic any day to report any experienced toxicities and speak with a healthcare professional.
- Percentage of subjects who have complete response or partial response and have 2+ or higher autophagy [ Time Frame: until clinical response (up to 2 years) ] [ Designated as safety issue: No ]
- Duration of response of this regimen [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]time from response until progression of disease/relapse
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Chloroquine, Velcade and Cyclophosphamide
Cyclophosphamide will be given at 50 mg orally twice per day daily, on days 1-14 and 22-35, the latter for the first cohort of 3 patients.
Other Names:Drug: Velcade
VELCADE will be given by intravenous push at 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29 and 32.
Other Names:Drug: Chloroquine
Chloroquine at 500 mg orally daily on days 1-14 and 21-35, the latter for the first cohort of 3 patients. If this dose of Chloroquine is tolerated, subsequent patients will receive Chloroquine at 500 mg twice a day on days 1-14 and 22-35.
Other Name: Aralen
The Purpose of this study is to test the safety of a combination of three anticancer medicines, called Chloroquine, Velcade and Cyclophosphamide. The cyclophosphamide will be used orally at doses that synergize with both VELCADE and chloroquine. The bid dose is chosen for cyclophosphamide to enable continuous exposure in this regard.
Here, the investigators propose to examine the hypothesis that combined exposure to Cyclophosphamide, VELCADE and Chloroquine will synergistically promote endoplasmic reticulum stress in multiple myeloma and thus synergistically lead to an antitumor effect measurable clinically.
|Contact: Amitbha Mazumder, MD||212-731-5757|
|United States, New York|
|NYU Cancer Institute||Recruiting|
|New York, New York, United States, 10016|
|Contact: Sara Marcus 212-263-4403 firstname.lastname@example.org|
|Principal Investigator:||Amitabha Mazumder, MD||NYU Langone Medical Center|