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

NCT01530594 | Completed Phase 3

• 1 other identifier: 2081-113
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Untreated; Without intent for immediate autologous stem cell transplant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lenalidomide

ACTIVE COMPARATOR

Lenalidomide/Low dose Dex (LLD)

Drug: Lenalidomide/Low dose Dex; Drug: Lenalidomide

Bortezomib/Lenalidomide

EXPERIMENTAL

Bortezomib/Lenalidomide/ Low dose Dex (BLLD)

Drug: Bortezomib/Lenalidomide/ Low dose Dex

Interventions

Lenalidomide/Low dose Dex DRUG

Lenalidomide/Low dose Dex (LLD)

Lenalidomide

Bortezomib/Lenalidomide/ Low dose Dex DRUG

Bortezomib/Lenalidomide/ Low dose Dex (BLLD)

Bortezomib/Lenalidomide

Lenalidomide DRUG

Lenalidomide/Low dose Dex (LLD

Lenalidomide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital &Reseach Center

Riyadh, 11211, Saudi Arabia

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: February 10, 2012
• Study Start: January 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 25, 2016

Record last verified: 2012-02

Locations

SA (1)