Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: 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 cyc
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
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 •Creatinine clearance •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
Exclusion criteria: •Peripheral neuropathy >=grade 2 •COPD with FEV1 •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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| â?¢Toxicity â?¢Progression free survival â?¢Time to progression â?¢Overall survival Timepoint: â?¢ Time to progression(TTP) will be defined as the duration from enrolment until disease progression (PD), with deaths from causes other than progression censored. â?¢ Progression free survival (PFS) will be defined as duration from enrolment until PD or death (regardless of cause), whichever came first. â?¢ 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 | — |
Primary
| Measure | Time frame |
|---|---|
| â?¢Overall response rates (CR/sCR, VGPR, PR)Timepoint: â?¢Overall response rates (CR/sCR, VGPR, PR) | — |
Countries
India
Contacts
Public ContactSudhir kumar
AIIMS, New Delhi
Outcome results
None listed