Health Condition 1: C900- Multiple myeloma Health Condition 2: null- Newly diagnosed cases of multiple myeloma
Conditions
Interventions
Intervention1: Arm A PVd: Arm A: PVd (Bortezomib, Pomalidomide with low-dose dexamethasone)
Inj Bortezomib 1.3mg/m2 SC on days 1,8, 15, 22
Cap Pomalidomide 4 mg days 1 to 21
Tab Dexamethasone 40 m
Sponsors
Dr Lalit Kumar
Eligibility
Inclusion criteria
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 f) Adequate liver function (serum bilirubin 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 i) Pregnancy test negative for female patients of reproductive age j) Willing to participate (provide written informed consent)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the progression-free survival in the two groups PVd and VRdTimepoint: At end of 16 weeks of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the response rates CR VGPR and PR in the two groups To assess the difference in the toxicity profile in the two groups To estimate the overall survival in the two groups To analyze the quality of life of patients using the EORTC C30 version 3 quality of life questionnaireTimepoint: At the end of 4 cycles of therapy | — |
Countries
India
Contacts
Public ContactDr Lalit Kumar
AIIMS, New Delhi
Outcome results
None listed