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

• ClinicalTrials.gov Identifier: NCT02272803
• Recruitment Status: Active, not recruiting
• First Posted: October 23, 2014
• Results First Posted: March 22, 2018
• Last Update Posted: May 18, 2020
• Sponsor: Bristol-Myers Squibb
• Collaborator: AbbVie
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: Lenalidomide; Drug: Dexamethasone; Biological: Elotuzumab (BMS-901608)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 22, 2015
• Actual Primary Completion Date: February 9, 2017
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
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	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	Drug: Lenalidomide; Drug: Dexamethasone

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Japan

Local Institution

Nagoya-shi, Aichi, Japan, 4600001

Local Institution

Nagoya-shi, Aichi, Japan, 4678602

Local Institution

Aomori-shi, Aomori, Japan, 0308553

Local Institution

Chiba-shi, Chiba, Japan, 2608677

Local Institution

Kamogawa-shi, Chiba, Japan, 2968602

Local Institution

Matsuyama-shi, Ehime, Japan, 7900024

Local Institution

Fukuoka-shi, Fukuoka, Japan, 8128582

Local Institution

Maebashi-shi, Gunma, Japan, 3718511

Local Institution

Shibukawa-shi, Gunma, Japan, 3770280

Local Institution

Fukuyama-shi, Hiroshima, Japan, 7200001

Local Institution

Morioka-shi, Iwate, Japan, 0208505

Local Institution

Kagoshima-shi, Kagoshima, Japan, 8920853

Local Institution

Kyoto-shi, Kyoto, Japan, 6028566

Local Institution

Sendai-shi, Miyagi, Japan, 9808574

Local Institution

Niigata-shi, Niigata, Japan, 9518566

Local Institution

Okayama-shi, Okayama, Japan, 7011192

Local Institution

Osaka-shi, Osaka, Japan, 5300012

Local Institution

Osaka-shi, Osaka, Japan, 5438555

Local Institution

Kawagoe-shi, Saitama, Japan, 3508550

Local Institution

Hamamatsu-shi, Shizuoka, Japan, 4313192

Local Institution

Utsunomiya-shi, Tochigi, Japan, 3200834

Local Institution

Bunkyo-ku, Tokyo, Japan, 1138677

Local Institution

Koto-ku, Tokyo, Japan, 1358550

Local Institution

Shibuya-ku, Tokyo, Japan, 1508935

Local Institution

Shinjuku-Ku, Tokyo, Japan, 1608582

Local Institution

Shinjuku-ku, Tokyo, Japan, 1628655

Local Institution

Tachikawa-shi, Tokyo, Japan, 1900014

Local Institution

Kasama-shi, Japan, 3091793

Sponsors and Collaborators

Bristol-Myers Squibb

AbbVie

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:

Statistical Analysis Plan  [PDF] April 2, 2017

Study Protocol  [PDF] February 16, 2017

More Information

Additional Information:

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

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02272803
• Other Study ID Numbers: CA204-116
• First Posted: October 23, 2014
• Results First Posted: March 22, 2018
• Last Update Posted: May 18, 2020
• Last Verified: May 2020

• 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

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; Lenalidomide; Elotuzumab; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors