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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01530594
First received: January 23, 2012
Last updated: February 24, 2016
Last verified: February 2012
  Purpose
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 Intervention Phase
Multiple Myeloma
Drug: Lenalidomide/Low dose Dex
Drug: Bortezomib/Lenalidomide/ Low dose Dex
Drug: Lenalidomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

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 [ Time Frame: Four years ] [ Designated as safety issue: Yes ]

Enrollment: 440
Study Start Date: January 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01530594

Locations
Saudi Arabia
King Faisal Specialist Hospital &Reseach Center
Riyadh, Saudi Arabia, 11211
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
  More Information

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01530594     History of Changes
Other Study ID Numbers: 2081-113 
Study First Received: January 23, 2012
Last Updated: February 24, 2016
Health Authority: United States: Federal Government
Saudi Arabia: Ethics Committee

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
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 29, 2016