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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:
ClinicalTrials.gov Identifier:
NCT01239797
First Posted: November 11, 2010
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
November 8, 2010
November 11, 2010
August 4, 2016
January 5, 2017
September 26, 2017
March 28, 2011
September 2, 2014   (Final data collection date for primary outcome measure)
  • Median Progression Free Survival (PFS) [ Time Frame: Randomization until 326 events (approximately 2 years) ]
    Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
  • Objective Response Rate (ORR) [ Time Frame: Randomization to end of treatment (approximately 2 years) ]
    Objective response rate (ORR) defined as the proportion of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
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) ]
Complete list of historical versions of study NCT01239797 on ClinicalTrials.gov Archive Site
  • Median Overall Survival (OS) [ Time Frame: Randomization to 427 deaths (approximately 7 years) ]
    Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.
  • Change in Baseline of Brief Pain Inventory-Short Form (BPI-SF) Scores [ Time Frame: Baseline to Study Completion (up to 7 years) ]
    Outcome measure reports the change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference between the two treatments using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
  • 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) ]
  • 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) ]
Not Provided
Not Provided
 
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lymphoma
  • 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 (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:
    • Decadron®
    • Dexamethasone Intensol®
    • Dexpak®
    • Taperpak®
  • 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:
    • Decadron®
    • Dexamethasone Intensol®
    • Dexpak®
    • Taperpak®
  • 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
  • Active Comparator: Lenalidomide + Dexamethasone
    Interventions:
    • Drug: Lenalidomide
    • Drug: Dexamethasone
  • Experimental: Lenalidomide + Dexamethasone +Elotuzumab
    Interventions:
    • Drug: Lenalidomide
    • Drug: Dexamethasone (Oral)
    • Drug: Dexamethasone (IV)
    • Biological: Elotuzumab (BMS-901608; HuLuc63)
Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Röllig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654. Epub 2015 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
761
October 1, 2018
September 2, 2014   (Final data collection date for primary outcome measure)

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

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:

    1. Best response achieved was ≥Partial Response (PR)
    2. Patient was not refractory
    3. Patient did not discontinue due to a Grade ≥3 related adverse event
    4. 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Poland,   Puerto Rico,   Romania,   Spain,   Switzerland,   Turkey,   United Kingdom,   United States
Czech Republic,   Russian Federation
 
NCT01239797
CA204-004
2010-020347-12 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
AbbVie
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2017

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