Phase II Study of Simvastatin for Relapsed/Refractory Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01332617|
Recruitment Status : Withdrawn (Investigators no longer interested in activating study)
First Posted : April 11, 2011
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myeloma||Drug: Simvastatin,Zoledronic Acid,Bortezomib,Bendamustine,Methylprednisolone.||Phase 2|
Primary To estimate the overall response rate (ORR) (complete response (CR) + very good partial response (VGPR) + partial response (PR)) of patients with multiple myeloma who have relapsed or are refractory after bortezomib treatment and will now receive a combination therapy of simvastatin, zoledronic acid, bortezomib, bendamustine and methylprednisolone.
To evaluate safety and tolerability of studied therapy.
- To estimate the progression-free Survival (PFS), time to progression (TTP), overall survival (OS) and duration of response (DOR).
- To describe toxicities (frequency and severity) during the treatment. 3 To estimate clinical benefit response (CBR) (ORR + minor response (MR)) and stable disease (SD).
4 Explore factors associated with ORR, PFS, OS, toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine and Methylprednisolone for Relapsed/Refractory Myeloma|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Treatment with combination therapy
Treatment with combination therapy of Simvastatin, Zoledronic Acid, Bortezomib, Bendamustine, and Methylprednisolone.
Drug: Simvastatin,Zoledronic Acid,Bortezomib,Bendamustine,Methylprednisolone.
- Response to treatment as defined by The International Myeloma Working Group response criteria for multiple myeloma. [ Time Frame: 4 weeks after first dose of simvastatin ]
Response catergories (IMWG):
Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Minor Response (MR), Progressive Disease (PD), Stable Disease, Relapse,Refractory Disease, Overall Response.
- Progression Free Survival (PFS) [ Time Frame: After 1 year of follow-up. ]PFS is measured from date of study enrollment until the date of progressive disease is documented.
- Incidence Rate of Toxicity [ Time Frame: End of study; monitoring during study. ]Decriptive statistics will be provided regarding incidence rates of toxcity. Patients will be monitored for safety throughout the study.
- Overall Survival (OS) [ Time Frame: After 1 year of follow-up ]OS is measured from date of study enrollment until death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332617
|Principal Investigator:||Geoffrey Herzig, MD||James Graham Brown Cancer Center- University of Louisville|