Main info

Identificatie:

HO87 MM

Sponsor:

HOVON

Working group party:

Myeloma

Age:

> 65

Stadium:

1st lijn

Echelon:

Level D

Included patients:

668

(of 668)

Active sites:

107

(of 49)

Title:

Randomized phase III trial in elderly patients with previously untreated symptomatic Multiple Myeloma comparing MP-Thalidomide (MP-Thal) followed by thalidomide maintenance versus MP-Lenalidomide (MP-Len) followed by maintenance with lenalidomide.

Timeline

Flow

Details

Phase:

Prospective Phase III study

Monitoring Type:

Not any more

Objectives:

Primary endpoint

• Progression free survival, defined as time from registration to progression or death from any cause
• Response rate defined as sCR, CR or VGPR

Secondary endpoints

• Overall response rate defined as sCR, CR, VGPR or PR
• Overall survival, measured from time of registration
• Quality of response during maintenance, measured as improvement of response (from start maintenance till progression)
• Time to maximum response, defined as time from registration to maximum response
• Time to death from relapse/progression (after initial response), measured from time of first relapse/progression
• Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC), version 3.0
• Quality of life as defined by the EORTC QLQ-C30 definitions.

Eligibility

Inclusion Criteria:

• Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria (see appendix A)
• Age > 65 years or patients ≤ 65 not eligible for high dose chemotherapy and peripheral stem cell transplantation
• WHO performance status 0-3 for patients <75 years and WHO performance status 0-2 for patients ≥ 75 years (see appendix E)
• Measurable disease as defined by the presence of M-protein in serum or urine or proven plasmacytoma by biopsy (see appendix A for definitions)
• Written informed consent

Exclusion Criteria:

• Non-secretory MM
• Known hypersensitivity to thalidomide
• Systemic AL amyloidosis
• Polyneuropathy, grade 2 or higher
• Severe cardiac dysfunction (NYHA classification II-IV, appendix F)
• Severe pulmonary dysfunction
• Significant hepatic dysfunction (total bilirubin ≥ 30 μmol/l or transaminases ≥ 3 times normal level), unless related to myeloma
• Creatinine clearance <30 ml/min
• 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
• History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
• Not able and/or not willing to use adequate contraception
• Pregnancy

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals