Multiple Myeloma Cancer Multiple myeloma and malignant plasma cell neoplasms
Conditions
Interventions
There are two main pathways:
1. Intensive for 'younger/fitter' patients
2. Non-intensive for 'older/less fit' patients
There are three randomised comparisons within each pathway.
1. Intensive pathwa
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or greater 2. Newly diagnosed as having symptomatic multiple myeloma or non secretory multiple myeloma based on: 2.1. Paraprotein (M-protein) in serum and/or urine 2.2. Bone marrow clonal plasma cells or plasmacytoma 2.3. Related organ or tissue impairment 3. Written informed consent 4. Prepared to use contraception 5. Negative pregnancy test
Exclusion criteria
Exclusion criteria: 1. Asymptomatic myeloma 2. Solitary plasmacytoma of bone 3. Extramedullary plasmacytoma (without evidence of myeloma) 4. Previous or concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas 5. Previous treatment for myeloma, except the following: 5.1. local radiotherapy to relieve bone pain or spinal cord compression 5.2. prior bisphosphonate treatment 5.3. low-dose corticosteroids (up to 12 mg/day dexamethasone or 80 mg/day prednisolone, for 14 days) 5.4. up to four single doses of corticosteroids (total dose 1 g methylperdnisolone, 200 mg dexamethasone, or 1.25 g prenisolone) Caution is advised in patients with a past history of ischaemic heart disease or psychiatric disorders, but exclusion is essentially to be at the discretion of the treating clinician. 6. Acute renal failure (unresponsive to up to 72 h of rehydration characterised by creatine >500 µmol/l or urine output 2 x upper limit or normal (or creatinine clearance 30 ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall survival 2. Progression-free survival 3. Response | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of Life 2. Skeletal related events 3. Toxicity 4. Thromboembolic events 5. Renal toxicity 6. Haematologic toxicity 7. Graft versus Host Disease (GvHD) | — |
Countries
New Zealand, South Africa, United Kingdom
Outcome results
None listed