This pilot clinical trial studies how well simvastatin works in overcoming chemotherapy resistance in patients with multiple myeloma that has come back or does not respond to treatment. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To examine the effect of simvastatin on myeloma (M)-protein and/or free light chains ratio when added to conventional chemotherapy for the treatment of multiple myeloma patients who have received up to 3 (=\< 3) and \> 3 different chemotherapy regimens. (group A and group B) SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS), time to progression (TTP), and duration of response (DOR) in group A, group B, and both groups combined. II. To describe toxicities (frequency and severity during the treatment) in group A, group B, and both groups combined. III. To estimate overall response (OR) in group A, group B, and both groups combined. IV. To evaluate the quality of life (QoL) of patients on the combined treatment in group A, group B, and both groups combined. OUTLINE: Patients receive standard of care chemotherapy for up to 3 courses and simvastatin orally (PO) daily 2 days before the first dose of chemotherapy for up to 2 days after the last dose of chemotherapy. Treatment with simvastatin continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 3-5 weeks for the first 6 months, and every 1-3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Change in free light chain ratios
The success rate will be estimated overall and within the strata groups and 95% confidence intervals will be calculated around the estimate. Will also estimate the change in free light chain ratios and provide confidence intervals for those estimates, both overall and within groups.
Time frame: Up to 126 Days
Change in M-protein level measured using electrophoresis
The success rate will be estimated overall and within the strata groups and 95% confidence intervals will be calculated around the estimate. Will also estimate the change in M-proteins and provide confidence intervals for those estimates, both overall and within groups.
Time frame: Up to 126 Days
DOR
Will estimate the mean duration of response and provide confidence intervals in the subset of patients who respond. The proportion (with confidence interval) of subjects achieving a clinical benefit response will be calculated.
Time frame: Up to 28 months
Incidence of toxicities evaluated according to National Cancer Institute CTCAE version 4.0
Toxicity data (both frequency and severity) will be summarized descriptively by showing the number of subjects experiencing each type of toxicity by grade for those with a grade 2 or higher.
Time frame: Up to 28 months
OR including stringent complete remission (CR), CR, Partial Remission (PR), and very good PR
The proportion (with confidence interval) of subjects achieving a clinical benefit response will be calculated.
Time frame: Up to 28 months
Overall survival
Will be analyzed initially using Kaplan-Meier estimation.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 28 months
PFS
Will be analyzed initially using Kaplan-Meier estimation.
Time frame: Up to 28 months
QoL assessed using a survey designed by European Organization for Research and Treatment of Cancer (EORTC)
Quality of life outcomes from the EORTC survey will be summarized descriptively.
Time frame: Up to 126 Days
Response in patients who did and did not receive zoledronic acid with therapy
Subset analysis will be done on patients who received zoledronic acid as part of their treatment while on study vs those who did not receive zoledronic acid to assess differences in response.
Time frame: Up to 28 months
Time to first response
Will be analyzed initially using Kaplan-Meier estimation.
Time frame: Up to 28 months
Time to next therapy
Will be analyzed initially using Kaplan-Meier estimation.
Time frame: Up to 28 months
TTP
Will be analyzed initially using Kaplan-Meier estimation.
Time frame: Up to 28 months