Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT - 1)
This study is currently recruiting participants.
Verified January 2013 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01335399
First received: April 13, 2011
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Lenalidomide Drug: Dexamethasone Biological: Elotuzumab (BMS-901608; HuLuc63) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Lenalidomide
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment. [ Time Frame: Every 4 weeks (-1/+3 days) relative to the first dose of study medication. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective Response Rate - The percentage of patients who have a partial or complete response to study therapy. [ Time Frame: All response endpoints assessed every 4 weeks (-1/+3 days). ] [ Designated as safety issue: No ]
- Overall Survival - The period of time from study entry until the date of death or last known date alive. [ Time Frame: Survival will be assessed every 16 weeks in the Follow Up Phase of the trial. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 750 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | November 2018 |
| Estimated Primary Completion Date: | November 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 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
Other Name: Revlimid®
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
Other Names:
|
| Experimental: Lenalidomide + Dexamethasone + Elotuzumab |
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
Other Name: Revlimid®
Drug: Dexamethasone
Tablets, Oral, 28 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
Other Names:
Drug: Dexamethasone
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
Other Names:
Drug: Dexamethasone
Solution, 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
Other Names:
Biological: Elotuzumab (BMS-901608; HuLuc63)
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
Biological: Elotuzumab (BMS-901608; HuLuc63)
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
- have not received any prior systemic anti-myeloma therapy AND
- have measurable disease AND
- 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 CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old
Exclusion Criteria:
- Subjects with non-secretory or oligo-secretory or free light-chain only 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335399
Show 218 Study Locations
Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Show 218 Study LocationsSponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01335399 History of Changes |
| Other Study ID Numbers: | CA204-006, 2010-022445-20 |
| Study First Received: | April 13, 2011 |
| Last Updated: | January 4, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council Austria: Federal Office for Safety in Health Care Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Canada: Health Canada Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Germany: Paul-Ehrlich-Institut Germany: Federal Office for Radiation Protection Germany: Ministry of Health Greece: Ethics Committee Greece: National Organization of Medicines Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Poland: National Institute of Medicines Poland: Ministry of Health Poland: Ministry of Science and Higher Education Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Romania: Ministry of Public Health Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: FSI Scientific Center of Expertise of Medical Application Spain: Spanish Agency of Medicines Switzerland: Federal Office of Public Health Switzerland: Swissmedic Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Newly Diagnosed Previously Untreated |
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 Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids |
ClinicalTrials.gov processed this record on May 21, 2013