An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT02654132
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination
- Documented refractory or relapsed and refractory multiple myeloma
- Refractory to proteosome inhibitor and lenalidomide, and to last treatment
- Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment
- Measurable disease at screening
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Active plasma cell leukemia
- Prior treatment with pomalidomide
- Unable to tolerate thromboembolic prophylaxis while on the study
- Prior autologous stem cell transplant within 12 weeks
- 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 Elotuzumab Arm Elotuzumab Biological:Elotuzumab (BMS-901608; HuLuc63) * Solution, Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22) * Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1) Drug: Pomalidomide •Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone * Subjects ≤ 75 years old: •Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) * Subjects \> 75 years old: •Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Other Names: Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak Elotuzumab Arm Pomalidomide Biological:Elotuzumab (BMS-901608; HuLuc63) * Solution, Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22) * Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1) Drug: Pomalidomide •Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone * Subjects ≤ 75 years old: •Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) * Subjects \> 75 years old: •Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Other Names: Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak Control Arm Dexamethasone Drug: Pomalidomide • Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: • Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22 Subjects \> 75 years old: • Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22, Other Names: * Decadron * Dexamethasone Intensol * Dexpak * Taperpak Elotuzumab Arm Dexamethasone Biological:Elotuzumab (BMS-901608; HuLuc63) * Solution, Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22) * Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1) Drug: Pomalidomide •Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone * Subjects ≤ 75 years old: •Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) * Subjects \> 75 years old: •Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1\&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Other Names: Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak Control Arm Pomalidomide Drug: Pomalidomide • Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: • Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22 Subjects \> 75 years old: • Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22, Other Names: * Decadron * Dexamethasone Intensol * Dexpak * Taperpak
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) From randomization to date of progression or death (up to approximately 21 months) PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following:
1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) From first dose to disease progression (up to approximately 21 months) ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment
* CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow
* sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
* VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>= 90% reduction in serum M-protein level plus urine M-protein level \< 100 mg per 24 hour
* PR: \>= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hour.Overall Survival (OS) From randomization to death (up to approximately 52 months) OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up.
Trial Locations
- Locations (44)
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Investigative Clinical Research Of Indiana, Llc
🇺🇸Indianapolis, Indiana, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Beth Israel Comprehensive Cancer Center
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute.
🇺🇸Boston, Massachusetts, United States
Carolinas Healthcare System
🇺🇸Charlotte, North Carolina, United States
Va Pittsburgh Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
St Francis Hospital
🇺🇸Greenville, South Carolina, United States
Northern Utah Associates
🇺🇸Ogden, Utah, United States
University Of Washington
🇺🇸Seattle, Washington, United States
Local Institution
🇪🇸Valencia, Spain
Local Institution - 0048
🇨🇦Montreal, Quebec, Canada
Local Institution - 0019
🇫🇷Poitiers Cedex, France
Local Institution - 0022
🇫🇷Nantes Cedex 1, France
Local Institution - 0021
🇫🇷Paris Cedex 12, France
Local Institution - 0020
🇫🇷Pessac, France
Universitaetsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
St. Barbara-Klinik
🇩🇪Hamm, Germany
Local Institution - 0041
🇩🇪Heidelberg, Germany
Local Institution - 0056
🇩🇪Kiel, Germany
Klinikum Der Johannes Gutenberg Universitaet Mainz
🇩🇪Mainz, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Laiko University Hospital
🇬🇷Athens, Greece
Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona
🇮🇹Ancona, Italy
Alexandra General Hospital Of Athens
🇬🇷Athens, Greece
Local Institution - 0030
🇯🇵Nagoya-shi, Aichi, Japan
Local Institution - 0069
🇯🇵Morioka-shi, Iwate, Japan
Local Institution - 0031
🇯🇵Kyoto-shi, Kyoto, Japan
Local Institution - 0029
🇯🇵Niigata-shi, Niigata, Japan
Local Institution - 0027
🇯🇵Shibuya-ku, Tokyo, Japan
Local Institution - 0028
🇯🇵Tachikawa-shi, Tokyo, Japan
Local Institution - 0067
🇯🇵Kasama-shi, Japan
Local Institution - 0032
🇯🇵Okayama, Japan
Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
🇵🇱Chorzow, Poland
Oddzial Hematologii i Transplantacji Szpiku
🇵🇱Poznan, Poland
Local Institution - 0024
🇪🇸Madrid, Spain
Universita' La Sapienza
🇮🇹Roma, Italy
A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino
🇮🇹Torino, Italy
Tennessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
CISSS de l'Outaouais
🇨🇦Gatineau, Quebec, Canada