Back to resultsLenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Lenalidomide/Low dose Dex
Bortezomib/Lenalidomide/ Low dose Dex
Lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Untreated, Without intent for immediate autologous stem cell transplant
Eligibility Criteria
- Patients must have newly diagnosed multiple myeloma
- 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.
- Patients must be ≥ 18 years of age at the time of registration.
- Patients must have a Zubrod Performance Status (PS) of 0 - 3
- Patients must have adequate marrow function as defined herein:
- Platelet count ≥ 80 x 103/mcL,
- ANC ≥ 1 x 103/mcL, and Hemoglobin (including patients who have been either transfused or treated with EPO) ≥ 9 g/dL.
- Institutions must submit a local cytogenetics report and FISH analysis report
- Patients with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity.
- Patients must have a calculated or measured creatinine clearance > 30 cc/min.
- Patients must not have uncontrolled, active infection requiring intravenous antibiotics
- Patients must not have any psychiatric illness
- Patients must not be Hepatitis B, Hepatitis C or HIV positive
- Patients must not have a history of cerebral vascular accident with persistent neurologic deficits.
- Patients must be able to take aspirin 325 mg daily
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
- 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.
- Patients must be offered participation in GEP molecular studies for the evaluation of genetic polymorphisms.
Sites / Locations
- King Faisal Specialist Hospital &Reseach Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lenalidomide
Bortezomib/Lenalidomide
Arm Description
Lenalidomide/Low dose Dex (LLD)
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01530594
First Posted
January 23, 2012
Last Updated
February 24, 2016
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01530594
Brief Title
Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma
Official Title
Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Untreated, Without intent for immediate autologous stem cell transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lenalidomide
Arm Type
Active Comparator
Arm Description
Lenalidomide/Low dose Dex (LLD)
Arm Title
Bortezomib/Lenalidomide
Arm Type
Experimental
Arm Description
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
Intervention Type
Drug
Intervention Name(s)
Lenalidomide/Low dose Dex
Intervention Description
Lenalidomide/Low dose Dex (LLD)
Intervention Type
Drug
Intervention Name(s)
Bortezomib/Lenalidomide/ Low dose Dex
Intervention Description
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide/Low dose Dex (LLD
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients must have newly diagnosed multiple myeloma
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.
Patients must be ≥ 18 years of age at the time of registration.
Patients must have a Zubrod Performance Status (PS) of 0 - 3
Patients must have adequate marrow function as defined herein:
Platelet count ≥ 80 x 103/mcL,
ANC ≥ 1 x 103/mcL, and Hemoglobin (including patients who have been either transfused or treated with EPO) ≥ 9 g/dL.
Institutions must submit a local cytogenetics report and FISH analysis report
Patients with pathologic fractures, pneumonia at diagnosis or symptomatic hyperviscosity.
Patients must have a calculated or measured creatinine clearance > 30 cc/min.
Patients must not have uncontrolled, active infection requiring intravenous antibiotics
Patients must not have any psychiatric illness
Patients must not be Hepatitis B, Hepatitis C or HIV positive
Patients must not have a history of cerebral vascular accident with persistent neurologic deficits.
Patients must be able to take aspirin 325 mg daily
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
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.
Patients must be offered participation in GEP molecular studies for the evaluation of genetic polymorphisms.
Facility Information:
Facility Name
King Faisal Specialist Hospital &Reseach Center
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma
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