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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02272803
First received: October 21, 2014
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Multiple Myeloma Drug: Lenalidomide Drug: Dexamethasone Biological: Elotuzumab (BMS-901608) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The difference in ORR between Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone therapy [ Time Frame: Approximately 24 months ]
  • Progression Free Survival (PFS) in Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone therapy [ Time Frame: Approximately 60 months ]

Enrollment: 90
Actual Study Start Date: January 22, 2015
Estimated Study Completion Date: December 31, 2020
Primary Completion Date: February 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02272803

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
Kasama-shi, Ibaraki, Japan, 3091793
Local Institution
Morioka-shi, Iwate, Japan, 0208505
Local Institution
Kagoshima-shi, Kagoshima, Japan, 8920853
Local Institution
Kyoto-shi, Kyoto, Japan, 6028566
Local Institution
Sendai, Miyagi, Japan, 9808574
Local Institution
Niigata-shi, Niigata, Japan, 9518566
Local Institution
Okayama-shi, Okayama, Japan, 7011192
Local Institution
Osaka-shi, Osaka, Japan, 5438555
Local Institution
Kawagoe-shi, Saitama, Japan, 3508550
Local Institution
Hamamatsu-shi, Shizuoka, Japan, 4313192
Local Institution
Utsunomiya, 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
Osaka, Japan, 5300012
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02272803     History of Changes
Other Study ID Numbers: CA204-116
Study First Received: October 21, 2014
Last Updated: April 17, 2017

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
Thalidomide
BB 1101
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

ClinicalTrials.gov processed this record on June 22, 2017