Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma

Phase 3

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Bortezomib-Melphalan; Drug: Melphalan

• Registration Number: NCT02197221
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Phase III multicenter randomized, open-label study comparing the efficacy of a combined high dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplant in frontline multiple myeloma patients, non-progressive after induction therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Study Start: 2015-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Must have results from their initial diagnosis available at the time of screening to confirm all the following :

  1. Diagnosis of multiple myeloma according to the diagnostic
  2. Symptomatic de novo Multiple Myeloma

• Be eligible for high-dose therapy with autologous stem cell transplantation

• Autologous cell graft with a total number of CD 34 cells > or = 5 X 106/kg before freezing

Exclusion Criteria

• Progressive disease
• Females participants pregnant or breast-feeding
• A known infection by the human immunodeficiency virus
• An active viral hepatitis B or C
• Unstable angina or myocardial infarction within 4 months prior to inclusion, heart failure NYHA class III or IV angina, uncontrolled, history of severe coronary artery disease, an uncontrolled serious ventricular arrhythmia, a sick sinus syndrome, or electrocardiographic evidence of acute ischemia or conduction disturbances grade 3 unless the patient has a pacemaker
• Uncontrolled hypertension or uncontrolled diabetes within 14 days before enrollment
• A history of another malignancy. If cancer was diagnosed more than 10 years and considered as cured, an authorization may be requested on a case-by-case basis after discussion with the principal investigator
• A significant neuropathy of grade 3-4 or grade 2 with pain in the 14 days prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bortezomib-Melphalan	Bortezomib-Melphalan	Bortezomib will be administered on days: -6, -3 +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.
Melphalan	Melphalan	Melphalan will be administered on day -2. The PBSC will be injected on day 0.

Primary Outcome Measures

Name	Time	Method
overall survival	60 months
Complete Response rates (according to IMWG 2011 criteria)	60 days post Autologous Stem Cells Transplantation

Secondary Outcome Measures

Name	Time	Method
progression-free survival between the two arms	60 months
Response rates (according to IMWG 2011 criteria)	post ASCT and consolidation therapy	Compare response rate after ASCT and after the completion of consolidation therapy
Serious adverse event	End of study

Trial Locations

Locations (46)

Clinique Universitaire Saint Luc; 🇧🇪 Bruxelles, Belgium

Grand Hôpital de Charleroi - Site Notre-Dame; 🇧🇪 Charleroi, Belgium

Chu Liege; 🇧🇪 Liege, Belgium

CHU Dinant-Godinne UCL Namur; 🇧🇪 Yvoir, Belgium

CH sud Réunion; 🇫🇷 Saint Pierre, ILE DE LA Reunion, France

Hôpital Felix Guyon; 🇫🇷 St-denis, ILE DE LA Reunion, France

CHU Amiens; 🇫🇷 Amiens, France

Chu Angers; 🇫🇷 Angers, France

CH Argenteuil Victor Dupouy; 🇫🇷 Argenteuil, France

CH Bayonne; 🇫🇷 Bayonne, France

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