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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Lenalidomide/Low dose Dex
* Drug: Bortezomib/Lenalidomide/ Low dose Dex
* Drug: Lenalidomide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lenalidomide<br>Lenalidomide/Low dose Dex (LLD) | Drug: Lenalidomide/Low dose Dex<br>* Lenalidomide/Low dose Dex (LLD)<br>Drug: Lenalidomide<br>* Lenalidomide/Low dose Dex (LLD<br>|
| Experimental: Bortezomib/Lenalidomide<br>Bortezomib/Lenalidomide/ Low dose Dex (BLLD) | Drug: Bortezomib/Lenalidomide/ Low dose Dex<br>* Bortezomib/Lenalidomide/ Low dose Dex (BLLD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | Four years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Untreated, Without intent for immediate autologous stem cell transplant