Trial Outcomes & Findings for Overcoming Chemotherapy Resistance In Refractory Multiple Myeloma With Simvastatin and Zoledronic Acid (NCT NCT01772719)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

4 weeks after treatment begins

Results posted on

2019-11-18

Participant Flow

7 subjects were enrolled into this trial by the investigator from medical clinic

Participant milestones

Participant milestones
Measure	Simvastatin and Zoledronic Acid Simvastatin and zoledronic acid: 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.
Overall Study STARTED	7
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Simvastatin and Zoledronic Acid Simvastatin and zoledronic acid: 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.
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	2
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Overcoming Chemotherapy Resistance In Refractory Multiple Myeloma With Simvastatin and Zoledronic Acid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Arm n=7 Participants Study Arm Simvastatin and zoledronic acid: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after treatment begins

Population: NA = Not available, Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At start of year 2 of follow-up on all surviving participants

Population: Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study

OS(Overall survival) is measured from date of study enrollment until death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Year 1 follow up visits occur monthly

Population: Study Terminated, zero total participants analyzed

Response will be accessed by one of the study investigators at each monthly follow up visit during year one.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At start of year 2 follow up on all surviving participants

Population: Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study

Study will estimate PFS when there is one year of follow up data for all surviving participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Year 2 follow up visit occur every three months

Population: Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study

Response will be assessed by one of the study investigators at each three month follow up visit for Year 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Year 3-5 follow up visit occurs every six months

Population: Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study

Response will be assessed by one of the study investigators at each six month follow up visit for Year 3-5

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 12 months up to one month after treatment completion

Population: Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study

Descriptive statistics will be provided regarding incidence rates of toxicity. Patients will be monitored for safety throughout the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 months after last treatment has been completed

Population: Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study

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

Outcome measures

Outcome data not reported

Adverse Events

Study Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Graham Brown Cancer Center, Clinical Trials

University of Louisville, James Graham Brown Cancer Center

Phone: 502-562-3429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place