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| [ Print-friendly version ] |
| Myelomatosis therapy trial for patients of all age groups |
| ISRCTN | ISRCTN68454111 |
| DOI | 10.1186/ISRCTN68454111 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Myelomatosis therapy trial for patients of all age groups |
| Scientific title | |
| Acronym | MRC Myeloma IX |
| Serial number at source | G0100132 |
| Study hypothesis |
1. Therapeutic questions within the intensive pathway:
1. 1. To compare an oral induction regimen containing thalidomide with a standard infusional induction chemotherapy, CTD versus CVAD, with respect to overall/progression-free survival and response. 1.2. To investigate the effects of giving additional consolidation therapy in the form of a low intensity conditioning allogeneic stem cell transplantation on survival. 2. Therapeutic questions within the non-intensive pathway: 2.1. To compare attenuated C-Thal-Dex (CTDa) with standard MP with respect to overall/progression-free survival and response. 3. Therapeutic questions across both pathways: 3.1. To assess the value of low dose thalidomide in maintenance in improving overall and progression-free survival. 3.2. To compare an aminobisphosphonate, zoledronic acid, with standard clodronate on the severity of bone disease and in improving survival. 3.3. To investigate quality of life in the short-term (during induction chemotherapy/bisphosphonate treatment) and in the long-term (during maintenance therapy). 3.4. To investigate prognostic factors for outcome. 4. Biological objectives: 4.1. To determine the clinical relevance of genetic/cytogenetic changes present at presentation in the definition of prognostic groups. 4.2. To determine the relevance of cellular phenotypes at presentation and to subsequently use these data to monitor residual disease. 4.3. To evaluate serum free light chain (flc) measurement as a prognostic factor and in monitoring disease. |
| Lay summary | http://cancerhelp.cancerresearchuk.org/trials/a-trial-comparing-treatments-for-myeloma |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | New Zealand, South Africa, United Kingdom |
| Disease/condition/study domain | Multiple Myeloma |
| Participants - 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 |
| Participants - 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 <400 ml/day or requirement for dialysis). These patients are not eligible for this study but may be eligible for inclusion in MERIT (Myeloma Renal Impairment Trial). NB Patients with serum creatinine >2 x upper limit or normal (or creatinine clearance <20 ml/min) are eligible for Myeloma IX, but bisphosphonates should not be administered until serum creatinine has decreased to <2 x upper limit of normal (or creatinine clearance >30 ml/min) |
| Anticipated start date | 14/05/2003 |
| Anticipated end date | 31/07/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 1930 |
| 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 pathway At diagnosis: 1.1. Cyclophosphamide, vincristine, adriamycin, dexamethasone (CVAD) versus cyclophosphamide, thalidomide, dexamethasone (CTD) 1.2. Clodronate versus Zoledronic acid After high dose consolidation therapy (HDT): 1.3. Thalidomide versus no maintenance therapy In addition, following standard high dose melphalan with autograft, patients with an available tissue-compatible sibling donor may be offered a reduced intensity conditioning allograft, if appropriate. 2. Non-intensive pathway At diagnosis: 2.1. Melphalan, prednisolone (MP) versus cyclophosphamide, thalidomide, dexamethasone (attenuated) (CTDa) 2.2. Clodronate versus Zoledronic acid After achievement of plateau state: 2.3. Thalidomide versus no maintenance therapy |
| Primary outcome measure(s) |
1. Overall survival
2. Progression-free survival 3. Response |
| Secondary outcome measure(s) |
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) |
| Sources of funding | Medical Research Council (MRC) (UK) |
| Trial website | |
| Publications |
1. 2005 interim results in http://www.ncbi.nlm.nih.gov/pubmed/16166766
2. 2010 results on homozygous deletion mapping in myeloma samples in http://www.ncbi.nlm.nih.gov/pubmed/20215539 3. 2010 results on genomic profiling of multiple myeloma in http://www.ncbi.nlm.nih.gov/pubmed/20616218 4. 2010 results on XBP1s levels in multiple myeloma in http://www.ncbi.nlm.nih.gov/pubmed/20421453 5. 2011 results on CTD initial therapy in http://www.ncbi.nlm.nih.gov/pubmed/21652683 6. 2011 results on secondary outcomes in http://www.ncbi.nlm.nih.gov/pubmed/21771568 7. 2011 results and meta-analysis in http://www.ncbi.nlm.nih.gov/pubmed/22021371 8. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22058209 9. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21856767 10. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22573403 |
| Contact name | Ms Louise Flanagan |
| Address |
Clinical Trials Research Unit
University of Leeds |
| City/town | Leeds |
| Zip/Postcode | LS2 9JT |
| Country | United Kingdom |
| Tel | +44 (0)113 343 6441 |
| Fax | +44 (0)113 343 6427 |
| l.m.flanagan@leeds.ac.uk | |
| Sponsor | University of Leeds (UK) |
| Address |
c/o Clinical Trials Research Unit (CTRU)
University of Leeds 17 Springfield Mount |
| City/town | Leeds |
| Zip/Postcode | LS2 9NG |
| Country | United Kingdom |
| Date applied | 21/09/2000 |
| Last edited | 03/08/2012 |
| Date ISRCTN assigned | 21/09/2000 |
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