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Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan

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ClinicalTrials.gov Identifier: NCT02272803
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

October 21, 2014
October 23, 2014
January 26, 2018
March 22, 2018
March 22, 2018
January 22, 2015
February 9, 2017   (Final data collection date for primary outcome measure)
Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld) [ Time Frame: From first dose until documented response (assessed up to February 2017, approximately 24 months) ]
ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
Objective Response Rate (ORR) - The percentage of patients who have a partial or better response to Lenalidomide/Dexamethasone + Elotuzumab therapy [ Time Frame: Approximately 24 months ]
Complete list of historical versions of study NCT02272803 on ClinicalTrials.gov Archive Site
  • Objective Response Rate (ORR) in All Treated Participants [ Time Frame: From first dose until documented response (assessed up to February 2017, approximately 24 months) ]
    ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
  • Progression Free Survival (PFS) in Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone Therapy [ Time Frame: From randomization to the date of first documented tumor progression or death due to any cause (assessed up to February 2017, approximately 24 months) ]
    PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the IMWG response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.
  • PFS Rate at 1 Year [ Time Frame: 1 year ]
    The number of participants with PFS at 1 year post-randomization was divided by the total number randomized in that arm and expressed as a percentage. PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the IMWG response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.
The difference in ORR between Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone therapy [ Time Frame: Approximately 24 months ]
Not Provided
Not Provided
 
Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
A Phase 2, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma in Japan
The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Lenalidomide
  • Drug: Dexamethasone
  • Biological: Elotuzumab (BMS-901608)
  • Experimental: Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)

    Drug: Lenalidomide

    Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

    Drug: Dexamethasone

    Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

    Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

    Biological: Elotuzumab (BMS-901608)

    Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

    Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

    Interventions:
    • Drug: Lenalidomide
    • Drug: Dexamethasone
    • Biological: Elotuzumab (BMS-901608)
  • Active Comparator: Arm B: Lenalidomide + Dexamethasone

    Drug: Lenalidomide

    Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

    Drug: Dexamethasone

    Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

    Interventions:
    • Drug: Lenalidomide
    • Drug: Dexamethasone
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
90
80
December 31, 2020
February 9, 2017   (Final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Newly diagnosed with symptomatic Multiple Myeloma (MM)
  • Have not received any prior systemic anti-myeloma therapy
  • Have measurable disease
  • Are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-116 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

Exclusion Criteria:

  • Non-secretory myeloma
  • Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
  • Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Active plasma cell leukemia
  • Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT02272803
CA204-116
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
AbbVie
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2018

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