Optimising Renal Outcome in Myeloma Renal Failure

Inclusion Criteria

• •Participant is willing and able to give informed consent for participation in the trial.
• •Patients attending NHS (National Health Service) Haemato-oncology centres.
• •Patients with newly diagnosed symptomatic myeloma.
• •Glomerular Filtration Rate (GFR) \<30 mls/min.
• •Chronic kidney disease (CKD) staging is based on estimated or measured GFR. CKD stage 4 (15-29 ml/min) and CKD stage 5 (\<15 ml/min) are eligible to enter the study. It is expected centres will consider use of fluid resuscitation and pulsed dose of steroid therapy in this group of patients to salvage renal function prior to trial screening.
• •A number of patients with newly diagnosed myeloma and renal failure will have a pre-existing medical condition (hypertension, diabetes etc.) causing renal damage. Where there is a medical condition (e.g. hypertension, diabetes) which may cause renal damage, there must have been a further decline (≥15 mls/min GFR) between previous steady state and the study screening.
• •Female participants of childbearing potential and male patients whose partner is a woman of childbearing potential must be prepared to use contraception in accordance with (and consent to) the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention Programme.
• •Women of childbearing potential must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene-approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention.
• •Free of prior malignancies for ≥ 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, localised prostate cancer or carcinoma "in-situ" of the cervix or breast.
• •In the Investigator's opinion, is able and willing to comply with all trial requirements.
• •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.