Bendamustine based therapy in Multiple Myeloma

Phase 2

• Conditions: Health Condition 1: C900- Multiple myeloma

• Registration Number: CTRI/2020/02/023591
• Lead Sponsor: All India Institute of Medical Sciences

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: 0

Inclusion Criteria

•>=18 years with confirmed diagnosis of MM

•ECOG PS 0-2

•Relapsed and/or refractory after >=2 lines of therapy

•Pomalidomide and Bendamustine naive, received prior lenalidomide and determined to be refractory.

•Measurable disease as determined by one or more of following:

•Serum M protein >=0.5gm/dl

•Urine Bence Jones protein >200mg in 24 h

•In patients with light chain myeloma serum immunoglobulin free light chain >=10mg/dl or abnormal ratio as per IMWG criteria

•Adequate bone marrow function as defined by: Hb>=8g/dl, ANC>=1000/mm3 and platelets>=75,000/mm3

•Adequate LFT: T. bil <=2 times ULN, AST/ALT <=3 ULN

•Creatinine clearance <=45 ml/minute

•Written informed consent

•No contraindication to take Aspirin 75mg/d or if history of prior thrombosis, should agree to take warfarin/ LMWH.

•Participants of child bearing age should agree to use adequate contraceptives, avoid breast feeding, avoid donating sperm 28days before starting, during therapy and 28 days after end of therapy

Exclusion Criteria

•Peripheral neuropathy >=grade 2

•COPD with FEV1 <50% of predicted

•Asthma

•Congestive heart failure, myocardial infarction within 12 months prior to starting, unstable angina, poorly controlled angina.

•Allergy to compounds of similar biochemical composition to Bendamustine and pomalidomide

•Pregnant and lactating females

•PLHIV, hepatitis B and/or hepatitis C positive

•Active infection requiring systemic antibiotics/antivirals/antifungal within two weeks prior to enrolment

•Other malignancy within 2 years of enrolment

•Primary refractory multiple myeloma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified