A study to assess the effect of Resveratrol and Copper in reducing toxicity during bone marrow transplantation for multiple myeloma.

Not Applicable

• Conditions: Health Condition 1: null- Patients undergoing autologous hematopoietic stem cell transplantation for multiple myeloma at Tata Memorial Centre.

• Registration Number: CTRI/2018/02/011905
• Lead Sponsor: TMC Research Administrative Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.