Trial Outcomes & Findings for Phase II Study to Evaluate Fenofibrate Therapy in Patients With Smoldering or Symptomatic Multiple Myeloma (NCT NCT01965834)
NCT ID: NCT01965834
Last Updated: 2017-06-14
Results Overview
To determine response rate (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), and Partial Response (PR)) in multiple myeloma patients receiving oral fenofibrate therapy. Response will be measured by serum and urine protein electrophoresis and immunofixation, as well as by percentage of plasma cells present on bone marrow biopsy.
TERMINATED
PHASE2
6 participants
After two cycles, about 2 months
2017-06-14
Participant Flow
Participant milestones
| Measure |
Fenofibrate Therapy
Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Fenofibrate Therapy
Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
Baseline Characteristics
Phase II Study to Evaluate Fenofibrate Therapy in Patients With Smoldering or Symptomatic Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Fenofibrate Therapy
n=6 Participants
Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: After two cycles, about 2 monthsPopulation: No participants achieved response to protocol therapy (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), or Partial Response (PR)). Two (2) patients had stable disease (SD); one (1) patient achieved Stable Disease/clinical Progressive Disease, and three (3) patients had progressive disease (PD).
To determine response rate (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), and Partial Response (PR)) in multiple myeloma patients receiving oral fenofibrate therapy. Response will be measured by serum and urine protein electrophoresis and immunofixation, as well as by percentage of plasma cells present on bone marrow biopsy.
Outcome measures
| Measure |
Fenofibrate Therapy
n=6 Participants
Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.
|
|---|---|
|
Rate of Response in Participants Receiving Fenofibrate Therapy
Strict Complete Response (sCR)
|
0 participants
|
|
Rate of Response in Participants Receiving Fenofibrate Therapy
Complete response (CR)
|
0 participants
|
|
Rate of Response in Participants Receiving Fenofibrate Therapy
Very Good Partial Response (VgPR)
|
0 participants
|
|
Rate of Response in Participants Receiving Fenofibrate Therapy
Partial Response (PR)
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 8 monthsTo evaluate safety and tolerability of fenofibrate therapy in patients with multiple myeloma.
Outcome measures
| Measure |
Fenofibrate Therapy
n=6 Participants
Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.
|
|---|---|
|
Number of Subjects Experiencing Adverse Events
|
5 participants
|
SECONDARY outcome
Timeframe: 6 months, 12 monthsProportion of participants achieving progression-free survival. Measured from date of initiation of treatment (Day 1) to the earliest occurrence of any of the following events: documented disease progression, or death from any cause. Patients who are alive and progression-free will be censored at the date of last documented progression-free status.
Outcome measures
| Measure |
Fenofibrate Therapy
n=6 Participants
Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.
|
|---|---|
|
Proportion of Participants Achieving Progression-Free Survival
6 months
|
0 participants
|
|
Proportion of Participants Achieving Progression-Free Survival
12 months
|
0 participants
|
Adverse Events
Fenofibrate Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fenofibrate Therapy
n=6 participants at risk
Fenofibrate orally daily for each 28 day cycle, per study protocol.
Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine Increased
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 2
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Flu-like Symptoms
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Localized edema
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Back pain
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Bone pain
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place