Health Condition 1: null- TRIAL WOULD BE CONDUCTED ON PATIENTS OF MULTIPLE MYELOMA ON THERAPY
Conditions
Interventions
Intervention1: ntervention would only be done at evidence of biochemical relapse in myeloma patients on maintenance therapy: triple / double drug regimens already approved in multiple myeloma would be
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1.ALL ADULTS > 18 YRS WITH MULTIPLE MYELOMA INCLUDED 2. Performance Status must be ECOG > 2 3. Patients should have been on maintenance/ continuation therapy or observation after the initial line of therapy for at least 3 months prior to randomization. 4.Bone marrow studies at time of randomization must demonstrate plasma cells 5.Patients should have demonstrated evidence of â??biochemical relapseâ?? are defined as (a). Rise in serum M spike of at least 25% over nadir value with an absolute increase of at least 0.5 g/dl (b). In case of patients with with light chain only disease, there should be an increase of 25% in the dFLC (the difference in absolute values of involved and uninvolved light chains) from nadir dFLC
Exclusion criteria
Exclusion criteria: evidence of ongoing target organ damage at the time of randomization: a) Hemoglobin b) evidence of new onset or increasing bone pains or new bone lesions or extra medullary plasmacytomas c) Creatinine is > 2mg/dl and stable for at least 3 months d) Normal serum calcium e) evidence of amyloid induced organ dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to Progression Timepoint: 1.5 yrs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality Of Life (QoL) 2. Toxicity of Therapy. 3. OS 4 Time to Third Treatment Timepoint: 1.5 yrs | — |
Countries
India
Contacts
Public ContactVadlamani Surya Prakash
AIIMS, New Delhi
Outcome results
None listed