Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: pomalidomide, cyclophosphamide and dexamethasone: Pomalidomide 4 mg daily for 21 days
Cyclophosphamide 50mg once daily for 21 days
Dexamethasone 40 mg weekly
Cycle duration – 2
Sponsors
Dr Lingaraj Nayak
Eligibility
Inclusion criteria
Inclusion criteria: i) Subject is, in the investigator’s opinion, willing and able to comply with the protocol requirements. Ii) Age >18 years. iii) ECOG performance status iv) Life-expectancy > 3 months v) Symptomatic relapsed myeloma vi) Subjects with measurable M band (serum M-protein = 1 g/dL) and free light chain value (Baseline FLC ratio is abnormal ( 1.65) and involved light chain isotype (kappa or lambda) is =10 mg/dL vii) Received 2 lines of therapy (PI- based, and lenalidomide based regimen) viii) Subjects who received only 1 line of prior treatment must have demonstrated PD on or within 60 days of completion of the lenalidomide containing regimen (ie, lenalidomide refractory)
Exclusion criteria
Exclusion criteria: I) Subjects with non-secretory or oligo-secretory myeloma ii) Plasma cell leukemia Iii) Subjects with extra medullary myeloma Iv) Significant cardiac disease - Known or suspected cardiac amyloidosis - Congestive heart failure of Class III or IV of the NYHA classification; - Uncontrolled angina, hypertension or arrhythmia - Myocardial infarction in past 6 months - Any uncontrolled or severe cardiovascular disease V) Known HIV infection or active hepatitis B, or C Vi) Absolute neutrophil count Vii) Platelets viii) Total bilirubin >2 x ULN, or direct bilirubin >2.0 mg/dL. ix) AST or ALT > 3 x ULN X) Creatinine clearance (CrCl) Xi) Known hypersensitivity to Lenalidomide or cyclophosphamide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free SurvivalTimepoint: At 3 month, 6 month, 9 month and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rates(ORR)Timepoint: At 3 month, 6 month, 9 month and 1 year;Overall SurvivalTimepoint: The time from randomization to the date of death due to any cause;Time to progressionTimepoint: The time from randomization to the date of progression. | — |
Countries
India
Contacts
Public ContactLINGARAJ NAYAK
Tata memorial hospital, Mumbai
Outcome results
None listed