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

• Sponsor: King Faisal Specialist Hospital & Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01530594
• Collaborator: (none)
• Enrollment: 440
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 9.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Lenalidomide/Low dose Dex; Drug: Bortezomib/Lenalidomide/ Low dose Dex; Drug: Lenalidomide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Faisal Specialist Hospital &Reseach Center	Riyadh		Saudi Arabia	11211

Sponsors and Collaborators

• King Faisal Specialist Hospital & Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: King Faisal Specialist Hospital & Research Center
• ClinicalTrials.gov Identifier: NCT01530594
• Other Study ID Numbers: 2081-113
• First Posted: Feb 10, 2012
• Last Update Posted: Feb 25, 2016
• Last Verified: Feb 1, 2012

• Keywords provided by King Faisal Specialist Hospital & Research Center: Untreated; Without intent for immediate autologous stem cell transplant
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Lenalidomide; Bortezomib

Study Results

No Results Posted as of Feb 25, 2016