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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: March 14, 2013
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
 Biological: BMS-901608 (Elotuzumab)
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-901608 (Elotuzumab) 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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241292

Locations
Japan
Local Institution
Nagoya-Shi, Aichi, Japan, 4600001
Local Institution
Nagoya-Shi, Aichi, Japan, 4678602
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01241292     History of Changes
Other Study ID Numbers: CA204-005
Study First Received: November 4, 2010
Last Updated: March 14, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on May 22, 2013