Clinical trial NCT01241292: Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths
timeFrame: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
measure: Number of Participants With Clinically Relevant Vital Sign Findings
timeFrame: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
measure: Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests
timeFrame: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
measure: Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests
timeFrame: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
measure: Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests
timeFrame: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Secondary outcomes:
measure: Number of Participants With Best Overall Response - Treated Participants
timeFrame: Cycle 2 (Study Day 29) to last dose (assessed up to January 2017, approximately 71 months)
measure: Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3
timeFrame: Days 1, 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3
measure: Geometric Mean Minimum Observed Serum Elotuzumab Concentration (Cmin) During Cycles 1, 2, and 3
timeFrame: Days 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3
measure: Number of Participants Positive for Anti-Elotuzumab Anti-drug Antibodies - Treated Participants
timeFrame: First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Niigata-shi
country: Japan
facility: Local Institution
state: Niigata
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Iida S, Nagai H, Kinoshita G, Miyoshi M, Robbins M, Pandya D, Bleickardt E, Chou T. Elotuzumab with lenalidomide and dexamethasone for Japanese patients with relapsed/refractory multiple myeloma: phase 1 study. Int J Hematol. 2017 Mar;105(3):326-334. doi: 10.1007/s12185-016-2138-4. Epub 2016 Nov 15.