Myelomatosis therapy trial for patients of all age groups

Not Applicable

Completed

• Conditions: Multiple Myeloma; Cancer; Multiple myeloma and malignant plasma cell neoplasms

• Registration Number: ISRCTN68454111
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

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 11. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23995858 12. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23974194 13. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24733348 14. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25645353

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-09-21
• Study Completion: 2014-07-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1930

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Overall survival<br>2. Progression-free survival<br>3. Response

Secondary Outcome Measures

Name	Time	Method
1. Quality of Life<br>2. Skeletal related events<br>3. Toxicity<br>4. Thromboembolic events<br>5. Renal toxicity<br>6. Haematologic toxicity<br>7. Graft versus Host Disease (GvHD)