Pomalidomide Bortezomib dexamethasone in newly diagnosed Multiple Myeloma

Phase 2

• Conditions: Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

• Registration Number: CTRI/2019/10/021618
• Lead Sponsor: Tata Medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Symptomatic myeloma patients (as per IMWG criteria) of both sex, >= 18 years and <= 65 years and not treated previously for multiple myeloma.

2 Subjects must have measurable disease defined

by Serum M-protein >=1 g/dL, OR Urine M-protein >=200 mg/24 h, OR Serum FLC assay: involved FLC level >=10 mg/dL provided serum FLC ratio is abnormal.

3 Life expectancy >= 3 months & ECOG performance status 0 to 2. ECOG 3 patients who have myeloma related organ dysfunction eg. hypercalcemia, renal failure, cord compression etc. based on clinical discretion, may be recruited.

4 Patients must meet the following clinical laboratory criteria within 14 days of treatment

a.Adequate hepatic function described by serum ALT and AST and direct bilirubin

b.Absolute neutrophil count (ANC) >= 1.0 Ã? 109/L

c.Hemoglobin >= 8 g/dL (80 g/L) (subjects may be receiving red blood cell [RBC] transfusions)

d.Platelet count >= 75 Ã? 109/L (>= 30 Ã? 109/L if myeloma involvement in the bone marrow is > 50%)

5 Calculated creatinine clearance >= 30 ml/minute

6 Females of childbearing potential and Males even if surgically sterilized, both agreed to use contraception.

Exclusion Criteria

1.Plasma cell leukaemia, POEMS syndrome, Amyloidosis, prior myeloma systemic therapy and those who failed to fully recover from the reversible effects of prior chemotherapy.

2.Female patients who are both lactating and breastfeeding or pregnant

3.Uncontrolled cardiovascular conditions, uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within 6 months, evidence of mucosal or internal bleeding and/or platelet refractory.

4.Patient who had major surgery or radiotherapy

5.Treatment by corticosteroids if exceed the equivalent of 160 mg of dexamethasone.

6.Growth factors within 7 days prior to enrolment.

7.Uncontrolled hypertension, uncontrolled diabetes, infection requiring systemic antibiotic therapy or other serious infection within 14 days prior to first dose of study drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified