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

Multiple Myeloma Clinical Trial

Official title:

A Phase 2, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272803
• Other study ID #: CA204-116
• Status: Completed
• Phase: Phase 2
• Start date: February 20, 2015
• Est. completion date: July 21, 2021

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 21, 2021
• Est. primary completion date: February 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Lenalidomide

• Dexamethasone

Biological:
• Elotuzumab (BMS-901608)

Locations

Country	Name	City	State
Japan	Local Institution	Aomori-shi	Aomori
Japan	Local Institution	Bunkyo-ku	Tokyo
Japan	Local Institution	Chiba-shi	Chiba
Japan	Local Institution	Fukuoka-shi	Fukuoka
Japan	Local Institution	Fukuyama-shi	Hiroshima
Japan	Local Institution	Hamamatsu-shi	Shizuoka
Japan	Local Institution	Kagoshima-shi	Kagoshima
Japan	Local Institution	Kamogawa-shi	Chiba
Japan	Local Institution	Kasama-shi
Japan	Local Institution	Kawagoe-shi	Saitama
Japan	Local Institution	Koto-ku	Tokyo
Japan	Local Institution	Kyoto-shi	Kyoto
Japan	Local Institution	Maebashi-shi	Gunma
Japan	Local Institution	Matsuyama-shi	Ehime
Japan	Local Institution	Morioka-shi	Iwate
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Niigata-shi	Niigata
Japan	Local Institution	Okayama-shi	Okayama
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Sendai	Miyagi
Japan	Local Institution	Shibukawa-shi	Gunma
Japan	Local Institution	Shibuya-ku	Tokyo
Japan	Local Institution	Shinjuku-Ku	Tokyo
Japan	Local Institution	Shinjuku-ku	Tokyo
Japan	Local Institution	Tachikawa-shi	Tokyo
Japan	Local Institution	Utsunomiya-shi	Tochigi

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld)	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.	From first dose until documented response (assessed up to February 2017, approximately 24 months)
Secondary	Objective Response Rate (ORR)	ORR is the percentage of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (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.	From first dose until documented response, up to approximately 72 months
Secondary	Progression Free Survival (PFS)	PFS is defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the International Myeloma Working Group (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.	From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months
Secondary	Progression Free Survival (PFS) Rate	PFS rate is defined as the percentage of participants who have neither progressed nor died at the specified timepoints	From randomization up to the specified timepoints, up to 3 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form