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Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01241292
First received: November 4, 2010
Last updated: August 11, 2014
Last verified: July 2014

November 4, 2010
August 11, 2014
January 2011
February 2014   (final data collection date for primary outcome measure)
Assessment of safety and tolerability of Elotuzumab in combination with Lenalidomide and low dose Dexamethasone, based on the assessment of the Dose Limiting Toxicity (DLT) expression [ Time Frame: Within the first 28 days ] [ Designated as safety issue: Yes ]
Assessment of safety and tolerability of Elotuzumab in combination with Lenalidomide and low dose Dexamethasone, based on the assessment of the DLT expression [ Time Frame: Within the first 28 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01241292 on ClinicalTrials.gov Archive Site
  • Clinical activity based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria [ Time Frame: Day 1 of each cycle from cycle 2 ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetics [ Time Frame: Day 1, 8, 15 and 22 of cycle 1, Day 1 and 22 of cycle 2, Day 1 and 15 of cycle 3, Day 1 of cycle 4 and 6 and every 3 cycles thereafter ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: Day 1 of cycle 1, 2, 3, 4, 6 and every 3 cycles thereafter ] [ Designated as safety issue: No ]
  • Clinical activity based on the EBMT criteria [ Time Frame: Day 1 of each cycle from cycle 2 ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetics [ Time Frame: Day 1, 8, 15 and 22 of cycle 1, Day 1 and 22 of cycle 2, Day 1 and 15 of cycle 3, Day 1 of cycle 4 and 6 and every 3 cycles thereafter ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: Day 1 of cycle 1, 2, 3, 4, 6 and every 3 cycles thereafter ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone
Phase 1 Multiple Ascending Dose Study of Elotuzumab (BMS-901608) in Combination With Lenalidomide/Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan

The purpose of this study is to assess the safety and tolerability of Elotuzumab when given in combination with Lenalidomide and low-dose Dexamethasone in subjects with relapsed or refractory multiple myeloma (MM) in Japan.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Biological: BMS-901608 (Elotuzumab)
Injection, Intravenous, 10 or 20 mg/kg, Weekly at cycle 1 and 2, bi-weekly at cycle 3 and thereafter, Until disease progression or unacceptable toxicity became apparent
Experimental: BMS-901608 (Elotuzumab)
Intervention: Biological: BMS-901608 (Elotuzumab)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
August 2015
February 2014   (final data collection date for primary outcome measure)

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

  • Received between 1 to 4 prior lines of therapy
  • Measureable disease
  • Men and women of childbearing potential (WOCBP) must be using two acceptable methods of contraception
  • Men must agree to use a latex condom and a second form of birth control during sexual contact with WOCBP and must agree to not donate semen during study drug therapy
  • Subjects must be willing to refrain from blood donations during study drug therapy

Exclusion Criteria:

  • Subjects with non-secretory or oligo-secretory or light-chain only myeloma or active/prior plasma cell leukemia or known /suspect POEMS syndrome
  • Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
  • Unable to take aspirin daily as prophylactic anticoagulation therapy. Prior history of inability to tolerate weekly 40 mg dexamethasone
  • History of renal failure
  • History of clinical significant thrombosis, such as treatment for thrombosis was required
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01241292
CA204-005
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP