Feasibility and Efficacy of dose adjusted Melphalan ¨C Prednisone ¨C Bortezomib (MPV) in elderly patients >= 75 years of age with newly diagnosed Multiple Myeloma; a non-randomised phase II study

Completed

• Conditions: Multiple Myeloma; Bortezomib; Kahler

• Registration Number: NL-OMON21015
• Lead Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC, Clinical Trial CenterPostbus 20403000 CA RotterdamTel: 010 7041560Fax: 010 7041028e-mail: hdc@erasmusmc.nl

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

Previously untreated patients with a confirmed diagnosis of symptomatic multiple myelomaaccording to IMWG criteria (see appendix A)
- Age = 75 years
- WHO performance status 0-3, WHO 4 performance status is allowed when related to MM (see appendix E)
- Measurable disease as defined by the presence of M-protein in serum or urine and/or abnormal free light chain (FLC) ratio with involved FLC (see appendix A for definitions). (If plasmacytoma is the only measurable parameter, the patient is not allowed to be included in the study, because of difficult response evaluation).
- Patient gives consent for extra bone marrow, blood and skin biopsy sampling
- Written informed consent

Exclusion Criteria

- Non-secretory MM
- Systemic Amyloid Light-chain (AL) amyloidosis
- Polyneuropathy, grade 1 with pain or grade = 2
- Severe cardiac dysfunction (NYHA classification IV, appendix F)
- Severe pulmonary dysfunction defined as breathlessness at rest
- Significant hepatic dysfunction (total bilirubin = 30 ¦Ìmol/l or transaminases = 3 times normal level), unless related to MM
- Renal insufficiency requiring dialysis
- Patients with active, uncontrolled infections
- Pre-treatment with cytostatic drug, immunomodulatory drugs (IMiDs) or proteasome inhibitors. Radiotherapy or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed
- Patients known to be Human Immunodeficiency Virus (HIV)-positive
- Active malignancy other than MM requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Patients with plasma cell leukemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main endpoint for this trial is the discontinuation rate, i.e. the proportion of patients who cannot complete all 9 MPV cycles according to protocol.