A randomized phase III study to compare Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed by Bortezomib, Lenalidomide, Dexamethasone(VRD) consolidation and Lenalidomide maintenance in patients with newly diagnosed multiple myeloma

Phase 3

Completed

• Conditions: newly diagnosed mutiple myeloma; Cancer - Myeloma

• Registration Number: ACTRN12612000419864
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-13
• Study Completion: 2016-04-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III according to the International Staging System (ISS)
-Measurable disease as defined by the presence of M-protein in serum or urine (serum Mprotein > 10 g/l or urine M-protein > 200 mg/24 hours), or abnormal free light chain ratio;
-Age 18-65 years inclusive;
-World Health Organisation (WHO) performance status 0-3 (WHO=3 is allowed only when caused by MM and not by comorbid conditions)
-Negative pregnancy test at inclusion if applicable;
-Written informed consent.

Randomization 1
-WHO performance 0-2;
-Bilirubin and transaminases < 2.5 times the upper limit of normal values;
-A suitable stem cell graft containing at least 4 x 10^6 CD34+ cells/kg (or according to national guidelines).

Randomization 2
-Bilirubin and transaminases < 2.5 times the upper limit of normal values;
-Absolute Neutrophil Count >= 0.5 x 10^9/l and platelets > 20 x 10^9/l;
-Patient is able to adhere to the requirements of the Lenalidomide Pregnancy Prevention Risk Management Plan.

Exclusion Criteria

Known intolerance of Boron;
-Systemic light chain (AL) amyloidosis;
-Primary Plasmacell Leukemia;
-Non-secretory multiple myeloma (MM);
-Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 5 days for symptom control;
-Severe cardiac dysfunction (NYHA classification II-IV);
-Significant hepatic dysfunction (serum bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to myeloma;
-Patients with glomerular filtration rate (GFR) <15 ml/min,
-Patients known to be Human immunodeficiency virus (HIV)-positive;
-Patients with active, uncontrolled infections;
-Patients with neuropathy, Common Toxicity Criteria for Adverse Events (CTCAE) grade 2 or higher;
-Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
-Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);
-Lactating women.

Randomization 1
-Severe pulmonary, neurologic, or psychiatric disease;
CTCAE grade 3-4 polyneuropathy during Bortezomib treatment;
-Allogeneic Stem Cell Transplantation (Allo SCT) planned;
-Progressive disease.

Randomization 2
-Progressive disease;
-Neuropathy, except CTCAE grade 1;
-CTCAE grade 3-4 polyneuropathy during Bortezomib treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified