Bioequivalence study of Bortezomib 3.5 mg powder for solution for Injection and VELCADE 3.5 mg powder for solution for injection in Relapsed/Refractory Multiple Myeloma patients under fasting conditions

Phase 1

• Conditions: Health Condition 1: D758- Other specified diseases of bloodand blood-forming organsHealth Condition 2: null- Relapsed/Refractory Multiple Myeloma Patients

• Registration Number: CTRI/2013/12/004202
• Lead Sponsor: Dr Reddys Laboratories Limited

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

1.Patient and /or LAR or impartial witness able to give written informed consent for participation in the trial

2.Patients with histopathologically/cytologically confirmed multiple myeloma

3.Patient with an ECOG performance status of 0-2

4.Patient must have an adequate bone marrow, renal and hepatic function

5.Patient should be able to comply with study procedures in the opinion of the investigator

6.Life expectancy should be >3 months

Exclusion Criteria

1.Known hyper sensitivity to bortezomib, boron or to any of the excipients

2.If the patient had undergone prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks (28 days) prior to dosing in the study

3.Patients with known human immunodeficiency virus (HIV) infection.

4.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies

5.Any other condition or abnormal baseline findings that, in the investigatorâ??s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study

6.The receipt of an investigational medicinal product within a period of 30 days prior to the first dose of Investigational Medicinal Product for the current study

7.Patient with a history of difficulty in donating blood or difficulty in accessibility of veins

8.Acute diffuse infiltrative pulmonary and pericardial disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified