Bendamustine based therapy in Multiple Myeloma

Phase 2

Not yet recruiting

• Conditions: Multiple myeloma,

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

Brief Summary

Multiple myeloma (MM) remains an incurable disease and most patients eventually relapse with 5 year relative survival still around 40%. The prognosis is particularly poor in patients who have received atleast 3 prior lines of therapy, double refractory MM and those exposed to alkylating agents showing an event free survival and overall survival of 5 months and 13 months respectively. Newer regimens which are efficacious, safe and affordable are needed for continued disease control in relapsed and/or refractory MM (RRMM). Bendamustine is a unique bifunctional drug that has structutal similarities to both  alkylating agents and antimetabolites but is not cross resistant to alkylating agents. it is generally well tolerated and is suitable for patients with renal dysfunction. Preclinical and clical data support synergy between alkylating agents (like bendamustine) and immunomodulatory drugs(like pomalidomide). phase 1 data has established maximal tolerated dose of triplet regimen of Bendasmustine, Pomalidomide and Dexamethasone is heavily pretreated patients of RRMM. This study is intended to evaluate the efficacy and  tolerability of this triplet regimen in Indian population of RRMM.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-03
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 35

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.
• •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

Primary Outcome Measures

Name	Time	Method
•Overall response rates (CR/sCR, VGPR, PR)	•Overall response rates (CR/sCR, VGPR, PR)

Secondary Outcome Measures

Name	Time	Method
•Toxicity	•Progression free survival

Trial Locations

Locations (1)

All India Institute of Medical Sciences, New Delhi; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences, New Delhi

🇮🇳South, DELHI, India

Sudhir kumar

Principal investigator

9654237044

sudhirkirar@gmail.com