Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: Bortezomib: 1.3mg/m2 on day -1
Control Intervention1: G-CSF alone: 5mcg/kg BD for 5 days
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
Inclusion criteria: a)Patients with MM planned for ASCT at first response or after first relapse b) Age >45 years c) Normal cardiac functions d)Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. e)Signed informed consent
Exclusion criteria
Exclusion criteria: a)Any history of cardiac or autonomic side effects to Bortezomib b)Past history of pelvic radiotherapy c)Past history of treatment for any other malignancies d)Grade 3-4 peripheral neuropathy e)Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse. f)Not able to understand the investigative nature of the study or give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in the stem cell CD34 dose (4 x 106/kg) on a single day stem cell harvest with the addition of a single dose of Bortezomib along with G-CSFTimepoint: 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| a.Peripheral blood CD 34 counts on day 0 b.Neutrophil and platelet engraftment c.Transplant related mortality d.MRD negativity on day 100 e.3 year event free survival f.3 year overall survivalTimepoint: 3 years | — |
Countries
India
Contacts
Public ContactAnup J Devasia
Christian Medical College
Outcome results
None listed