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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530594
• Other study ID #: 2081-113
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2012
• Last updated: February 24, 2016
• Start date: January 2009
• Est. completion date: January 2013

Study information

• Verified date: February 2012
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentSaudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Lenalidomide/Low dose Dex
Lenalidomide/Low dose Dex (LLD)
• Bortezomib/Lenalidomide/ Low dose Dex
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
• Lenalidomide
Lenalidomide/Low dose Dex (LLD

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital &Reseach Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes