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:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01239797
First received: November 8, 2010
Last updated: August 7, 2014
Last verified: August 2014

November 8, 2010
August 7, 2014
March 2011
August 2017   (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: 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 ]
  • Objective response rate (ORR) of Elotuzumab and Lenalidomide / low-dose Dexamethasone [ Time Frame: Approximately up to 6.75 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01239797 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference using the Brief Pain Inventory-Short Form (BPI-SF) of LdE versus Ld [ Time Frame: Approximately up to 6.75 years ] [ Designated as safety issue: No ]

    Lenalidomide, (low-dose) Dexamethasone, Elotuzumab (LdE)

    Lenalidomide, (low-dose) Dexamethasone (Ld)

  • 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 ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma (Myeloma)
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
640
March 2018
August 2017   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Poland,   Puerto Rico,   Romania,   Spain,   Switzerland,   Turkey,   United Kingdom
 
NCT01239797
CA204-004, 2010-020347-12
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
AbbVie
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2014

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