Health Condition 1: null- Patients undergoing autologous hematopoietic stem cell transplantation for multiple myeloma at Tata Memorial Centre.
Conditions
Interventions
Intervention1: Trans-Resveratrol (Trade name â?? TransMaxTR) and Copper (Trade name â?? Chelated Copper): Trans-Resveratrol is available as a health supplement in capsule form (500mg) and is approved
Sponsors
TMC Research Administrative Council
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients 18 years and above. 2. Patients who have given written informed consent 3. Patients with performance status of 0,1 or 2 (ECOG scale) 4. Patients of multiple myeloma receiving melphalan- 200 mg/m2 (MEL-200 mg/m2) 5. Patients who have creatinine clearance > 50 ml/min 6. Patients with serum bilirubin levels < 2mg/dl and serum liver enzymes (ALT or AST or both) less than 5 times the upper limit of normal value.
Exclusion criteria
Exclusion criteria: 1. Patients who are on NSAIDs , aspirin ,antioxidants or systemic steroids for more than 3 months and the last dose taken within the last one week. 2. Patients being treated for active infection at the time of starting high dose chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the plasma and saliva levels of inflammatory cytokines (PGE2, TNF-α, INF-gamma, IL-6, IL-1 and CRP) at pre-defined time-points following administration of 4-dose-levels of R-Cu in patients receiving autologous transplant for multiple myeloma.Timepoint: To determine the plasma and saliva levels of inflammatory cytokines (PGE2, TNF-α, INF-gamma, IL-6, IL-1 and CRP) 2 days prior to start of high dose chemotherapy, on day 0 (ie day of stem cell infusion) and then every 3rd day till day 21 post transplant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To estimate total leukocyte, absolute neutrophil and platelet counts; to quantify DNA-damage, apoptosis and activation of inflammatory cytokines in PBMCs; to quantify serum lipid profiles at predefined time points following administration of 4-dose-levels of R-Cu. 2. To evaluate the steady-state PK parameters for resveratrol and copper on Day 7 in patients receiving autologous stem cell transplant at 4-dose levels of R-Cu.Timepoint: 48 hours prior to starting conditioning chemotherapy and then every 72 hours until 21 days post-transplant (days 0, 3, 6, 9, 12, 15, 18, 21), counting the day of stem cell infusion as day 0.;1. To quantify toxicities by NCI Common Toxicity Criteria version 4.03 in myeloma patients undergoing autologous stem cell transplant who have been administered 4-dose-levels of R-Cu. 2. To quantify serum chromatin levels at predefined time points following administration of 4-dose-levels of R-Cu in these patients.Timepoint: 48 hours prior to starting conditioning chemotherapy and then every 72 hours until 21 days post-transplant (days 0, 3, 6, 9, 12, 15, 18, 21), counting the day of stem cell infusion as day 0. | — |
Countries
India
Contacts
Public ContactProfessor Dr Indraneel Mittra
Tata Memorial Centre
Outcome results
None listed