A study on randomized comparison of two different regimen(PCD vs PD)in relapsed/refractory multiple myeloma after failure of PI and lenalidomide in previous line of treatment

Phase 3

Conditions: Health Condition 1: C900- Multiple myeloma

Registration Number: CTRI/2021/12/038872

Lead Sponsor: Dr Lingaraj Nayak

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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 < 2 (Unless explained by myeloma)

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 ( <0.26 or >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

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 < 1000 cells/mm3.

Vii) Platelets < 75,000 cell/mm3 (75 x 109/L).

viii) Total bilirubin >2 x ULN, or direct bilirubin >2.0 mg/dL.

ix) AST or ALT > 3 x ULN

X) Creatinine clearance (CrCl) < 30 mL/min by the Cockcroft and Gault formula

Xi) Known hypersensitivity to Lenalidomide or cyclophosphamide

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free SurvivalTimepoint: At 3 month, 6 month, 9 month and 1 year

Secondary Outcome Measures

Name	Time	Method
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.