TriangleNCT01772719 · REGISTRY CONDITION SEARCH
Overcoming Chemotherapy Resistance In Refractory Multiple Myeloma With Simvastatin and Zoledronic Acid
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- TERMINATED
- Registry last update
- 2019-11-18
The purpose of this study is to examine the effect of simvastatin and zoledronic acid on M-protein and/or free light chains when added to conventional chemotherapy for the treatment of multiple myeloma patients.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Change in Paraprotein Level and Free Light Chain (FLC) Ratio From Baseline Measurement
Overall Survival
Duration of Response
Progression Free Survival (PFS)
Duration of Response
Duration of Response
Incidence Rate of Toxicity
Comparison of Quality of Life Scores
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: 1. have a definitive diagnosis of Multiple Myeloma (using the International Myeloma Working Group Guidelines). 2. meet one of the following two requirements: * Have achieved minimal response (MR) or stable disease (SD) in current treatment regimen after a minimum of two cycles. * Have partial response but show no further improvement in paraprotein levels in the latest two measurements. 3. must have measurable active or symptomatic disease. Measurable disease may be paraprotein or free light chains in serum or urine, or the presence of bone marrow plasma cells, defined by one or more of the following criteria: * Presence of serum M-protein concentration \> 1g/dL. * Urine M-protein excretion \> 200mg in 24-hour urine collection. * Serum free light chain concentration ≥ 10mg/dL and abnormal kappa/lambda ratio. * Urine free light chain concentration ≥ 100mg/L and abnormal kappa/lambda ratio. * Bone marrow plasma cell percentage ≥ 30% (if no detectable M-protein or FLC.) 4. Age \> 18 years of age. 5. If female with reproductive capacity: on effective means of birth control during the entire duration of the treatment. 6. Patients must have recovered from acute toxicities resulting from therapy administered prior to entering this study to grade 1 or less (CTCAE 4) Alopecia may not be resolved. 7. Ability to understand and willingness to sign a written informed consent document. 8. Life expectancy of greater than 8 weeks. 9. ECOG performance status 0, 1, or 2 (Karnofsky \> 60%; see Appendix A). 10. have adequate bone marrow function as defined below: * absolute neutrophil count \> 500/ul * platelets \> 30,000/ul 11. have adequate liver function as defined below: * total bilirubin \< 2 times the upper limit of normal * AST(SGOT), ALT(SGPT) \< 3 x upper limit of normal 12. have adequate renal function as defined by a creatinine clearance \> 40 mL/min (measured or estimated by the Cockcroft-Gault formula). 13. have no signs of significant rhabdomyolysis determined by CPK levels with a CK \< 5 times the upper limit of normal. Exclusion Criteria: 1. have not received any chemotherapy treatment for multiple myeloma prior to being enrolled in the study. 2. show progressive disease or are not tolerating current chemotherapy regimen. 3. were receiving simvastatin (dose \> 40mg/day) while receiving current chemotherapy regimen for multiple myeloma. 4. failed or progressed on more than two chemotherapy regimens, including current treatment; prior to enrolling in this study. 5. receiving any other investigational agent(s). 6. Active second malignancy in the last 5 years except for non-melanoma skin cancer or carcinoma-in-situ. 7. Pregnant women are ineligible, as treatment involves unforeseeable risks to the embryo or fetus. Female patients with reproductive capacity are required to use effective means of birth control during the entire duration of the treatment. 8. History of hypersensitivity reactions attributed to simvastatin or zoledronic acid. 9. receiving medications that may increase risk of rhabdomyolysis such as itraconazole, ketoconazole, erythromycin, cyclosporine, amiodarone, verapamil, clarithromycin, nefazodone, ranolazine, HIV protease inhibitors, gemfibrozil, posaconazole, danazol, amiodarone, diltiazem and amlodipine. 10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myopathy, untreated hypothyroidism, hereditary myopathy in the family history, unstable angina pectoris, liver disease not due to multiple myeloma, cardiac arrhythmia that is symptomatic or not rate controlled, active connective tissue disease, active autoimmune disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Study Arm
- intervention Names
- Drug: Simvastatin and zoledronic acid
- label
- Study Arm
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Study Arm
- description
- 1. Simvastatin 80 mg PO daily starting two days before starting chemotherapy and stopping two days after chemotherapy. 2. Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly.
- name
- Simvastatin and zoledronic acid
- other Names
- Zocor
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 7
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The effect of simvastatin and zolendronic acid on M-Protein and FLC ratio will be measured 4 weeks after treatment begins, then every 4 weeks until progression of disease.
- measure
- Change in Paraprotein Level and Free Light Chain (FLC) Ratio From Baseline Measurement
- time Frame
- 4 weeks after treatment begins
- secondary Outcomes
- description
- OS(Overall survival) is measured from date of study enrollment until death.
- measure
- Overall Survival
- time Frame
- At start of year 2 of follow-up on all surviving participants
- description
- Response will be accessed by one of the study investigators at each monthly follow up visit during year one.
- measure
- Duration of Response
- time Frame
- Year 1 follow up visits occur monthly
- description
- Study will estimate PFS when there is one year of follow up data for all surviving participants
- measure
- Progression Free Survival (PFS)
- time Frame
- At start of year 2 follow up on all surviving participants
- description
- Response will be assessed by one of the study investigators at each three month follow up visit for Year 2
- measure
- Duration of Response
- time Frame
- Year 2 follow up visit occur every three months
- description
- Response will be assessed by one of the study investigators at each six month follow up visit for Year 3-5
- measure
- Duration of Response
- time Frame
- Year 3-5 follow up visit occurs every six months
- description
- Descriptive statistics will be provided regarding incidence rates of toxicity. Patients will be monitored for safety throughout the study.
- measure
- Incidence Rate of Toxicity
- time Frame
- Every 12 months up to one month after treatment completion
- description
- The QOL scores taken at the start of the study and every 4 months after treatment starts will be analyzed using Wilcoxon test for paired differences
- measure
- Comparison of Quality of Life Scores
- time Frame
- Up to 2 months after last treatment has been completed
Full study description
- brief Summary
- The purpose of this study is to examine the effect of simvastatin and zoledronic acid on M-protein and/or free light chains when added to conventional chemotherapy for the treatment of multiple myeloma patients.
- detailed Description
- We hypothesize that the addition of simvastatin and zoledronic acid to bortezomib, thalidomide, melphalan or dexamethasone based regimens will decrease drug resistance when treating refractory multiple myeloma. We hypothesize that the addition of simvastatin and zoledronic acid will not increase the chemotherapy toxicity significantly and will be tolerable for patients. We believe simvastatin and zoledronic acid have antitumor properties and will contribute to reversal of resistance. Treatment will be significantly enhanced when these agents are combined
Source references
Source notices and limitations
Discovery and provenance
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- source file
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Preserved source evidence · Not medical advice