Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Phase 3

Completed

• Conditions: Lymphoma; Multiple Myeloma
• Interventions: Drug: Lenalidomide; Drug: Dexamethasone; Drug: Dexamethasone (Oral); Drug: Dexamethasone (IV); Biological: Elotuzumab (BMS-901608; HuLuc63)

• Registration Number: NCT01239797
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Study Start: 2011-06-20
• Primary Completion: 2014-09-02
• Results First Submitted: 2016-08-04
• Results First Submitted QC: 2017-01-04
• Results First Posted: 2017-01-05
• Study Completion: 2021-04-21
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 646

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lenalidomide + Dexamethasone +Elotuzumab	Dexamethasone (IV)	-
Lenalidomide + Dexamethasone	Lenalidomide	-
Lenalidomide + Dexamethasone	Dexamethasone	-
Lenalidomide + Dexamethasone +Elotuzumab	Dexamethasone (Oral)	-
Lenalidomide + Dexamethasone +Elotuzumab	Elotuzumab (BMS-901608; HuLuc63)	-
Lenalidomide + Dexamethasone +Elotuzumab	Lenalidomide	-

Primary Outcome Measures

Name	Time	Method
Median Progression Free Survival (PFS)	From randomization up to 326 events (up to approximately 38 months)	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)	From randomization up to approximately 38 months	Objective response rate (ORR) defined as the percentage 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline of Mean Score Pain Severity (BPI-SF)	From baseline up to approximately 38 months	The change from baseline of the mean score of pain severity at the end of treatment 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.
Change From Baseline of Mean Score Pain Interference (BPI-SF)	From baseline up to approximately 38 months	The change from baseline of the mean score of pain interference at the end of treatment 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.
Median Overall Survival (OS)	Randomization to the date of death from any cause (up to approximately 9 years)	Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)

Trial Locations

Locations (39)

Northwest Alabama Cancer Center, Pc; 🇺🇸 Muscle Shoals, Alabama, United States

Acrc/Arizona Clinical Research Center, Inc.; 🇺🇸 Tucson, Arizona, United States

Local Institution; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Compassionate Cancer Res Grp; 🇺🇸 Corona, California, United States

San Diego Pacific Oncology& Hematology Associates, Inc; 🇺🇸 Encinitas, California, United States

Ucla-Division Of Hematology/Oncology; 🇺🇸 Los Angeles, California, United States

Medical Oncology Care Associates; 🇺🇸 Orange, California, United States

Sharp Clinical Oncology Research; 🇺🇸 San Diego, California, United States

Cancer Care Centers Of Florida; 🇺🇸 Brooksville, Florida, United States

Mount Sinai Comprehensive Cancer Center; 🇺🇸 Miami Beach, Florida, United States

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