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. (see Contacts and Locations)
Verified January 2014 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01335399
First received: April 13, 2011
Last updated: July 9, 2014
Last verified: January 2014

April 13, 2011
July 9, 2014
May 2011
May 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01335399 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

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)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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:
    • Decadron®
    • Dexamethasone Intensol®
    • Dexpak®
    • Taperpak®
  • 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:
    • Decadron®
    • Dexamethasone Intensol®
    • Dexpak®
    • Taperpak®
  • 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:
    • Decadron®
    • Dexamethasone Intensol®
    • Dexpak®
    • Taperpak®
  • 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:
    • Decadron®
    • Dexamethasone Intensol®
    • Dexpak®
    • Taperpak®
  • 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
  • Active Comparator: Lenalidomide + Dexamethasone
    Interventions:
    • Drug: Lenalidomide
    • Drug: Dexamethasone
  • Experimental: Lenalidomide + Dexamethasone + Elotuzumab
    Interventions:
    • Drug: Lenalidomide
    • Drug: Dexamethasone
    • Drug: Dexamethasone
    • Drug: Dexamethasone
    • Biological: Elotuzumab (BMS-901608; HuLuc63)
    • Biological: Elotuzumab (BMS-901608; HuLuc63)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
July 2020
May 2016   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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
Both
18 Years and older
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Switzerland,   Turkey,   United Kingdom
 
NCT01335399
CA204-006, 2010-022445-20
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
AbbVie
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP