A comparison of Bortezomib, Pomalidomide with low-dose Dexamethasone and Bortezomib, Lenalidomide with low-dose dexamethasone for newly-diagnosed multiple myeloma patients- A randomized phase III study.

Phase 3

• Conditions: Health Condition 1: C900- Multiple myelomaHealth Condition 2: null- Newly diagnosed cases of multiple myeloma

• Registration Number: CTRI/2019/07/020397
• Lead Sponsor: Dr Lalit Kumar

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a) Newly diagnosed cases of multiple myeloma with no prior chemotherapy (prior treatment with dexamethasone up to 2 weeks is acceptable). Prior localized or palliative radiotherapy is acceptable.

b)Durie- Salmon stage II and III, ISS stage I,II,III

c)Age between 18 and 70 years

d)ECOG performance status of 0 to 2

e)Serum creatinine of <=2.0 mg/dl

f)Adequate liver function (serum bilirubin <=1.5 mg/dl, AST and ALT < 2.5 times of upper limit of normal)

g)Adequate hemogram absolute neutrophil count >1000/ cu. mm. and platelet count >75,000/ cu.mm. and Hb >7g/dl

h)Pre-existing peripheral neuropathy < grade 2 at the time of enrollment

i)Pregnancy test negative for female patients of reproductive age

j)Willing to participate (provide written informed consent)

Exclusion Criteria

a) Prior treatment with Bortezomib, Lenalidomide or Thalidomide

b)Non-secretory multiple myeloma, monoclonal gammopathy of unknown significance (MGUS), or smoldering myeloma.

c)Uncontrolled diabetes mellitus

d)Uncontrolled hypertension, unstable angina, inadequate cardiac function (abnormal ECG: rhythm disturbances), acute myocardial infarction within the last 6 months

e)Severe psychiatric disorder that would make participation in the study difficult

f)History of hypersensitivity reaction to mannitol, boron or bortezomib

g)Patient is pregnant or lactating

h)Active acute infection requiring systemic antibiotics, antifungals or antivirals within 2 weeks prior to start of study drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified