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

Phase 2

Recruiting

• Conditions: Kahlers disease; Multiple Myeloma; 10035227

• Registration Number: NL-OMON47392
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

- Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria
- Age >= 75 years
- WHO performance status 0-3, WHO 4 performance status is allowed when related to MM
- 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. (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 amyloidosis
- Polyneuropathy, grade 1 with pain or >= grade 2
- Severe cardiac dysfunction (NYHA classification IV)
- Severe pulmonary dysfunction defined as breathlessness at rest
- Significant hepatic dysfunction (total bilirubin >= 30 µmol/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, 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 HIV-positive
- Active malignancy requiring treatment or having been treated with chemotherapy currently affecting bone marrow capacity. Non-active previous malignancies are allowed.
- 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
<p>Discontinuation rate, defined as the proportion of patients who received less<br /><br>than 9 cycles of MPV according to protocol treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Relative dose intensity of Melphalan, Prednisone and Bortezomib<br /><br>- Safety and toxicity as defined by type, frequency and severity of adverse<br /><br>events as defined by the National Cancer Institute (NCI) Common Terminology<br /><br>Criteria (CTC), version 4.0<br /><br>- Overall response rate defined as sCR, CR, VGPR or PR<br /><br>- Progression free survival, defined as time from registration to progression<br /><br>or death from any cause<br /><br>- Overall survival, measured from time of registration<br /><br>- Geriatric assessments<br /><br>- Quality of life as defined by the EORTC QLQ-C30 and MY-20 definitions.<br /><br>- Biomarkers for biological age<br /><br>- Genetic polymorphism analysis of genes involved in drug metabolism and<br /><br>related with bortezomib-induced PNP<br /><br>- Cost efficacy analysis</p><br>