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Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)


Inclusion Criteria:



- Documented progression from most recent line of therapy

- 1 - 3 prior lines of therapy

- Measurable disease

- Life expectancy ≥3 months

- Prior treatment with Lenalidomide permitted if:

1. Best response achieved was ≥ Partial Response (PR)

2. Patient was not refractory

3. Patient did not discontinue due to a Grade ≥ 3 related adverse event

4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9
months between the last dose of Lenalidomide and progression

Exclusion Criteria:

- Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma

- Active plasma cell leukemia

- Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment

Outcome Time Frame:

Tumor assessments every 4 weeks (±1 week) relative to the first dose of study medication (median length of time for tumor assessments should be approximately 13 months)

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CA204-004

NCT ID:

NCT01239797

Start Date:

June 2011

Completion Date:

October 2017

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Washington University School of MedicineSaint Louis, Missouri  63110
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Capitol Comprehensive Cancer Care ClinicJefferson City, Missouri  65109
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Tennessee Cancer SpecialistsKnoxville, Tennessee  37920
Medical Oncology Care AssociatesOrange, California  92668
Henry Ford Health SystemDetroit, Michigan  48202
Local InstitutionBronx, New York  
Local InstitutionVancouver, Washington  
Local InstitutionGreen Bay, Wisconsin  
ACRC/Arizona Clinical Research Center, Inc.Tucson, Arizona  85712
Local InstitutionBirmingham, Alabama  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionOklahoma City, Oklahoma  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Cancer Specialists of South Texas, PACorpus Christi, Texas  78412
Sharp Clinical Oncology ResearchSan Diego, California  92123
St. Luke's-Roosevelt Hospital CenterNew York, New York  
Local InstitutionLouisville, Kentucky  
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Local InstitutionDetroit, Michigan  
Investigative Clinical Research of Indiana, LLCIndianapolis, Indiana  46254
Northwest Alabama Cancer Center, PCFlorence, Alabama  35630
NYU Clinical Cancer CenterNew York, New York  10016
Pasco Hernando Oncology Associates, PANew Port Richey, Florida  34642
Northwest Cancer CenterHouston, Texas  77042
Weill Cornell Medical CollegeNew York, New York  10021
Mecklenburg Medical GroupCharlotte, North Carolina  
University of Texas SouthwesternDallas, Texas  75390
Charleston Hematology Oncology Associates, PACharleston, South Carolina  29403
Gaston Hematology & OncologyGastonia, North Carolina  28054
Compassionate Cancer Care Medical Group IncFountain Valley, California  92708
Cancer Institute Of FloridaOrlando, Florida  32804
St Johns Medical Research Institute, Inc.Springfield, Missouri  65807
San Diego Pacific Oncology& Hematology Associates, IncEncinitas, California  92024
Marin Cancer Care, IncGreenbrae, California  94904
Space Coastal Medical Assoc.Titusville, Florida  32796
Cancer Center Of Acadiana At Lafayette GeneralLafayette, Louisiana  70503
Willis Knighton Cancer CenterShreveport, Louisiana  71103
Univ Of Oklahoma Health Science CenterOklahoma City, Oklahoma  73104
Hematology-Oncology Associates Of Fredricksburg, IncFredricksburg, Virginia  22408