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CTRI Number  CTRI/2020/02/023591 [Registered on: 26/02/2020] Trial Registered Prospectively
Last Modified On: 18/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Bendamustine based therapy in Multiple Myeloma 
Scientific Title of Study   Bendamustine,Pomalidomide and Dexamethasone in Relapsed and/or refractory Multiple Myeloma 
Trial Acronym  BASiL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lalit Kumar 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 234, 2nd floor, Department of Medical Oncology, IRCH, AIIMS, New Delhi
Room no 234, 2nd floor, Department of Medical Oncology, IRCH, AIIMS, New Delhi
New Delhi
DELHI
110029
India 
Phone  011-26593405  
Fax    
Email  Lalitaiims@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Sudhir kumar 
Designation  Senior resident 
Affiliation  AIIMS, New Delhi 
Address  Room no 234, 2nd floor, Department of Medical Oncology, IRCH, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9654237044  
Fax    
Email  sudhirkirar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sudhir kumar 
Designation  Senior resident 
Affiliation  AIIMS, New Delhi 
Address  Room no 234, 2nd floor, Department of Medical Oncology, IRCH, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9654237044  
Fax    
Email  sudhirkirar@gmail.com  
 
Source of Monetary or Material Support  
Room no 234, 2nd floor, Department of Medical Oncology, IRCH, AIIMS, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  All India Institute of Medical Sciences Ansari Nagar, New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sudhir kumar  All India Institute of Medical Sciences, New Delhi   All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029
South
DELHI 		 9654237044

sudhirkirar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Comittee for Post Graduate Research, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C900||Multiple myeloma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bendamustine ,Pomalidomide and Dexamethasone  Bendamustine at 120mg/m2 iv infusion over 30-60 minutes every 28 days Pomalidomide 3mg per orally once daily day1 to day21 of a 28 day cycle. Dexamethasone 40mg once weekly(except in patients more than 75 years of age where 20mg will be used 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  •≥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

 
 
ExclusionCriteria 
Details 
•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.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Overall response rates (CR/sCR, VGPR, PR)   •Overall response rates (CR/sCR, VGPR, PR)  
 
Secondary Outcome  
Outcome  TimePoints 
•Toxicity
•Progression free survival
•Time to progression
•Overall survival
 		 • Time to progression(TTP) will be defined as the duration from enrolment until disease progression (PD), with deaths from causes other than progression censored.
• Progression free survival (PFS) will be defined as duration from enrolment until PD or death (regardless of cause), whichever came first.
• Overall survival (OS) will be defined as the time interval from enrolment to documented date of death
All those patients who started trial treatment will be evaluable for toxicity 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/03/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.
 
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