Trial record 1 of 1 for:
NCT01239797
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma (ELOQUENT - 2)
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01239797
First received: November 8, 2010
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 Drug: Dexamethasone (Oral) Drug: Dexamethasone (IV) 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: | Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM) |
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: Tumor assessments every 4 weeks (±1 week) relative to the first dose of study medication (median length of time for tumor assessments should be approximately 13 months) ] [ 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 week) (median length of the endpoint assessment period is projected to be approximately 13 months) ] [ 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 12 weeks in the Follow Up Phase of the trial (approximate length of the overall survival period is 6.75 years) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 640 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | March 2014 (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 (Oral)
On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug. On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug Other Names:
Drug: Dexamethasone (IV)
On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug Other Names:
Biological: Elotuzumab (BMS-901608; HuLuc63)
Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 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:
- Documented progression from most recent line of therapy
- 1 - 3 prior lines of therapy
- Measurable disease
- Life expectancy ≥3 months
Prior treatment with Lenalidomide permitted if:
- Best response achieved was ≥ Partial Response (PR)
- Patient was not refractory
- Patient did not discontinue due to a Grade ≥ 3 related adverse event
- Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
Exclusion Criteria:
- Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
- 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: NCT01239797
Show 211 Study Locations
Show 211 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: | NCT01239797 History of Changes |
| Other Study ID Numbers: | CA204-004, 2010-020347-12 |
| Study First Received: | November 8, 2010 |
| 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 Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: The Danish National Committee on Biomedical Research Ethics France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 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 Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices 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 Russia: Ministry of Health of the Russian Federation Russia: Ethics Committee Russia: FSI Scientific Center of Expertise of Medical Application Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
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 23, 2013