Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma

Phase 3

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Bortezomib/Lenalidomide/ Low dose Dex; Drug: Lenalidomide/Low dose Dex; Drug: Lenalidomide

• Registration Number: NCT01530594
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief Summary

This is a randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low dose dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide and low dose dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-01-23
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bortezomib/Lenalidomide	Bortezomib/Lenalidomide/ Low dose Dex	Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
Lenalidomide	Lenalidomide	Lenalidomide/Low dose Dex (LLD)
Lenalidomide	Lenalidomide/Low dose Dex	Lenalidomide/Low dose Dex (LLD)

Primary Outcome Measures

Name	Time	Method
comparison progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone	Four years

Trial Locations

Locations (1)

King Faisal Specialist Hospital &Reseach Center; 🇸🇦 Riyadh, Saudi Arabia