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

February 24, 2016 updated by: King Faisal Specialist Hospital & Research Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital &Reseach Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Patients must have newly diagnosed multiple myeloma
  2. Patients must have received no prior chemotherapy for this disease. Patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis). Prior steroid treatment is allowed provided treatment was not more than 2 weeks in duration. Patients must not have received any prior treatment with bortezomib or lenalidomide.
  3. Patients must be ≥ 18 years of age at the time of registration.
  4. Patients must have a Zubrod Performance Status (PS) of 0 - 3
  5. Patients must have adequate marrow function as defined herein:
  6. Platelet count ≥ 80 x 103/mcL,
  7. ANC ≥ 1 x 103/mcL, and Hemoglobin (including patients who have been either transfused or treated with EPO) ≥ 9 g/dL.
  8. Institutions must submit a local cytogenetics report and FISH analysis report
  9. Patients with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity.
  10. Patients must have a calculated or measured creatinine clearance > 30 cc/min.
  11. Patients must not have uncontrolled, active infection requiring intravenous antibiotics
  12. Patients must not have any psychiatric illness
  13. Patients must not be Hepatitis B, Hepatitis C or HIV positive
  14. Patients must not have a history of cerebral vascular accident with persistent neurologic deficits.
  15. Patients must be able to take aspirin 325 mg daily
  16. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
  17. No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
  18. Patients must be offered participation in GEP molecular studies for the evaluation of genetic polymorphisms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lenalidomide
Lenalidomide/Low dose Dex (LLD)
Drug: Lenalidomide/Low dose Dex
Lenalidomide/Low dose Dex (LLD)
Drug: Lenalidomide
Lenalidomide/Low dose Dex (LLD
Experimental: Bortezomib/Lenalidomide
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
Drug: Bortezomib/Lenalidomide/ Low dose Dex
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Four years
Four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Faisal Specialist Hospital & Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2081-113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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