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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

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ClinicalTrials.gov Identifier: NCT01530594
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : January 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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
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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 [ Time Frame: Four years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530594


Locations
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Saudi Arabia
King Faisal Specialist Hospital &Reseach Center
Riyadh, Saudi Arabia, 11211
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
More Information
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Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01530594    
Other Study ID Numbers: 2081-113
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2012
Keywords provided by King Faisal Specialist Hospital & Research Center:
Untreated
Without intent for immediate autologous stem cell transplant
Additional relevant MeSH terms:
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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
Lenalidomide
Bortezomib
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents