Chloroquine in Combination With VELCADE and Cyclophosphamide for Relapsed and Refractory Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT01438177|
Recruitment Status : Terminated (PI left institution.)
First Posted : September 21, 2011
Results First Posted : June 1, 2015
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Velcade Drug: Cyclophosphamide Drug: Chloroquine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Trial of Chloroquine in Combination With VELCADE and Cyclophosphamide in Patients With Relapsed and Refractory Myeloma|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.
Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.
Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.
Each cycle is 42 days in length.
Other Names:Drug: Cyclophosphamide
Other Names:Drug: Chloroquine
Other Name: Aralen
- Response Rate (CR + PR After 2 Cycles) [ Time Frame: Up to 2 years ]
Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria:
CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h
- Number of Participants With Adverse Events of Grade 3 or Higher [ Time Frame: Treatment period plus 30 days post-treatment ]Adverse events reported here were at least possibly related to the protocol therapy.
- 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) ]
- Median Duration of Response of This Regimen [ Time Frame: up to 2 years ]Duration of response is the time from response (CR or PR) until progression of disease or relapse. Responses and progression were evaluated based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438177
|United States, New York|
|NYU Cancer Institute|
|New York, New York, United States, 10016|
|Principal Investigator:||Amitabha Mazumder, MD||NYU Langone Medical Center|