The MM5 trial: evaluation of two regimens of bortezomib-based induction therapy and of lenalidomide consolidation followed by lenalidomide maintenance treatment in patients with multiple myeloma

Phase 3

Completed

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

• Registration Number: ISRCTN05622749
• Lead Sponsor: niversity Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)

Brief Summary

1. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25787915 (added 29/01/2019) 2. 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32034285 (added 10/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-27
• Study Completion: 2017-03-11
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

1. Confirmed diagnosis of multiple myeloma requiring systemic therapy
2. Measurable disease
3. Aged 18 - 70 years inclusive, either sex

Exclusion Criteria

1. Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression
2. Severe cardiac dysfunction
3. Significant hepatic dysfunction
4. Patients known to be human immunodeficiency virus (HIV)-positive
5. Patients with active, uncontrolled infections
6. Patients with peripheral neuropathy or neuropathic pain, Common Toxicity Criteria (CTC) grade 2 or higher
7. Patients with a history of active malignancy during the past 5 years
8. Systemic amyloid light chain (AL) amyloidosis
9. Pregnancy and lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified