A randomised comparison of thalidomide and lenalidomide combinations in myeloma patients of all ages

Phase 3

Completed

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

• Registration Number: ISRCTN49407852
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30559051 results for maintenance therapy with lenalidomide versus placebo 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31624047 response-adapted intensification treatment results (added 21/10/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33232472/ renal outcome results (added 25/11/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33262523/ results (added 03/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33428632/ results (added 12/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-29
• Study Completion: 2023-12-31
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4400

Inclusion Criteria

1. Aged 18 years or greater, either sex
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 and/or symptoms considered by the clinician to be myeloma related
3. Provide written informed consent
4. 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
5. Women of child bearing potential must have a negative pregnancy test in accordance with the Celgene approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention

Exclusion Criteria

1. Asymptomatic myeloma
2. Solitary plasmacytoma of bone (patients with previous solitary plasmacytoma that have now progressed to symptomatic or non-secretory myeloma are eligible)
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. Patients with remote histories (greater than 5 years) of other cured malignancies may be entered.
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. Corticosteroids within the last 3 months
6. Known history of allergy contributable to compounds containing boron or mannitol
7. Grade 2 or greater (National Cancer Institute [NCI] criteria) peripheral neuropathy
8. Caution is advised in patients 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
9. Acute renal failure (unresponsive to up to 72 hours of rehydration, characterised by creatinine greater than 500 µmol/l or urine output less than 400 ml/day or requirement for dialysis)

Added 02/06/2016:
1. Documented diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for high-risk disease
2. Patient has active or prior hepatitis C

Study & Design

• Study Type: Interventional
• Study Design: Not specified