A Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma
Trial overview
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Approximately up to 12 cycles of 3 weeks each
Number of participants with overall response rate
Timeframe: Approximately up to 12 cycles of 3 weeks
Number of participants with partial response (PR) as best response (BR)
Timeframe: Up to 12 cycles of 3 weeks each
Number of Participants With Minor Response (MR) as Best Response (BR)
Timeframe: Up to 12 cycles of 3 weeks each
Number of Participants With Partial Response (PR) as Last Observed Response (LOR)
Timeframe: Up to 12 cycles of 3 weeks each
Number of Participants With Stable Disease (SD) as Best Response (BR)
Timeframe: Up to 12 cycles of 3 weeks each
Number of Participants With Stable Disease (SD) as Last Observed Response (LOR)
Timeframe: Up to 12 cycles of 3 weeks each
Number of Participants With Progressive Disease (PD) PD as Best Response (BR)
Timeframe: Up to 12 cycles of 3 weeks each
Number of Participants With Progressive Disease (PD) PD as Last Observed Response (LOR)
Timeframe: Up to 12 cycles of 3 weeks each
Time to disease progression
Timeframe: From Day 1 till disease progression (approximately 12 cycles of 3 weeks each)
Change from Baseline in hematology: White blood cell (WBC) count, Neutrophils, Lymphocytes, Platelets
Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
Change from Baseline in hematology: Hematocrit
Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
Change from Baseline in hematology: Hemoglobin
Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
Change from Baseline in hematology: Red blood cell (RBC)
Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
Change from in Baseline biochemistry: Serum Creatinine, Total Bilirubin
Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
Change from Baseline in biochemistry -urea, bicarbonate
Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
Change from Baseline in biochemistry: Prothrombin time (PT)/ International normalized ratio (INR)
Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)
Plasma concentrations of SRT501 at indicated time points
Timeframe: Cycle 1 Day 1, Cycle 1 Day 2 and Cycle 1 Day 20 at pre-dose, 30 minute, 1 hour, 2 hour, 4 hour, 6 hour and 24 hour post-dose. Day 2 and Day 20, samples collected post-dose. Each cycle duration was 21 days.
Participation criteria
- Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
- Subject was previously diagnosed with Multiple Myeloma and has failed at least one
- Intolerance to resveratrol, SRT501 or bortezomib or significant allergy to either
- compound, boron or mannitol or significant prior toxicity with either agent that would
- Subject must be male or female ≥ 18 years at the time of signing Informed Consent.
- Subject was previously diagnosed with Multiple Myeloma and has failed at least one prior treatment regimen for the disease.
- Subject must have measurable disease.
- Subjects must have relapsed or relapsed/refractory disease as defined in Appendix 4.
- Subject must have a life expectancy of greater than 6 months.
- Subject has an ECOG Performance status of 0 to 2 (Appendix 2).
- Subject has no prior history of HIV-1, HIV-2, Hepatitis B or C infection.
- Subject has a normal 12 lead ECG or an ECG with an abnormality considered to be clinically insignificant.
- Subject has the ability to communicate with the investigative site staff in a manner sufficient to carry out all protocol procedures as described.
- Subject must be able to adhere to the study visit schedule and other protocol requirements.
- Subject must understand and voluntarily sign an informed consent document.
- All subjects of reproductive potential must agree prior to study entry to use adequate contraception (hormonal or double barrier method of birth control; abstinence) for the duration of the study dosing and at least 12 weeks after completion of study drug.
- Total bilirubin < 2 x ULN, unless attributable to Gilbert’s disease
- ALT (SGPT) and AST (SGOT) < 2.5 x ULN
- Creatinine < 2.0 x ULN
- ANC > 0.5 x 10^9/L
- Platelets > 20,000 cells/mm3
Adequate end organ function, defined as the following:
- Intolerance to resveratrol, SRT501 or bortezomib or significant allergy to either compound, boron or mannitol or significant prior toxicity with either agent that would preclude the safe use of that agent. Prior therapy with either compound is permitted.
- Subjects with other active malignancy, with the exception of basal cell or squamous cell carcinoma of the skin.
- An uncontrolled intercurrent illness including, but not limited to, recent (≤ 6 months), ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, acute diffuse infiltrative pulmonary or pericardial disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subject with a history of or current gastro-intestinal diseases influencing drug absorption, with the exception of an appendectomy.
- Women who are breast-feeding, pregnant, expect to become pregnant during the course of the study, or are sexually active in a heterosexual relationship and are not using a medically acceptable double barrier method birth control. Confirmation that the subject is not pregnant must be established by a negative serum beta-hCG pregnancy test result obtained during the Screening period. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Women relying solely on oral contraceptives for birth control are excluded.
- Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to signing Informed Consent or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Subjects who are on any concurrent medications that may exhibit anti-neoplastic therapy, with the exception of < 10 mg of prednisone or equivalent as indicated for other medical conditions, or up to 100 mg of hydrocortisone as premedication for administration of certain medications or blood products.
- Subjects currently taking any investigational therapies and/or dietary supplements containing resveratrol.
- Subjects with peripheral neuropathy of Grade 2 or greater.
- Subjects with uncontrolled bleeding.
- Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count ≥ 20,000 cells/mm3).
- Subjects with a hemoglobin < 8.0 g/dL. Transfusions and/or EPO treatment are permitted in subjects who are potentially excluded by this criteria.
- Any condition, including laboratory abnormalities, that in the opinion of the Investigator, would preclude treatment.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.