Myeloma XI is intended to be a unifying trial addressing issues in patients of all ages and providing a strategy within which to introduce new treatments as they become available.
There are two distinct treatment pathways.
Intensive pathway: for younger/fitter patients where intensive HDT with stem cell support is considered appropriate. Comparing a thalidomide-containing regimen with a lenalidomide-containing regimen, as induction treatment prior to HDT.
Non-intensive pathway: for older/less fit patients where standard-dose chemotherapy is considered appropriate. To compare an attenuated thalidomide-containing regimen with an attenuated lenalidomide-containing regimen.
Patients with the following characteristics are eligible for this trial:
Aged 18 years or greater.
Newly diagnosed as having symptomatic multiple myeloma or non-secretory multiple myeloma based on:
Paraprotein (M-protein) in serum and/or urine.
Bone marrow clonal plasma cells or plasmacytoma.
Related organ or tissue impairment and/or symptoms considered by the clinician to be myeloma related.
Provide written informed consent.
Women of childbearing potential and male patients whose partner is a woman of child bearing 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, or commit to absolute and continuous abstinence.
Women of child bearing 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.
Participants with the following characteristics are ineligible for this trial:
Asymptomatic myeloma (Appendix A)
Solitary plasmacytoma of bone (Appendix A). (Participants with previous solitary plasmacytoma now progressed to symptomatic or non-secretory myeloma are eligible).
Extramedullary plasmacytoma (without evidence of myeloma)
Previous or concurrent active malignancies.
Documented diagnosis of Myelodysplastic Syndrome (MDS).
Previous treatment for myeloma, except the following:
o local radiotherapy to relieve bone pain or spinal cord compression
o prior bisphosphonate treatment
Known history of allergy contributable to compounds containing boron or mannitol
Grade 2 or greater (NCI criteria) peripheral neuropathy
Caution is advised in participants with a past history of ischaemic heart disease, pericardial disease, acute diffuse infiltrative pulmonary disease or psychiatric
disorders, evidence of impaired marrow function or elevated liver function tests, but exclusion is essentially to be at the discretion of the treating clinician
Acute renal failure (unresponsive to up to 72 hours of rehydration, characterised by creatinine >500 μmol/L or urine output <400 mL/day or requirement for dialysis)
Lactating or breastfeeding.
Tel: 0113 2067436
E-mail: [email protected]
Dr Gordon Cook
Tel: 0113 2068433
E-mail: [email protected]
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Other trials currently active for Multiple Myeloma and related disorders
A randomised phase II trial of Cyclophosphamide and Dexamethasone in combination with Ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenalidomide and bortezomib
A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, velcade and dexamethasone (CVD) for first relapse and primary refractory multiple myeloma