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)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
Sites / Locations
- Winship Cancer Institute
- Rush University Medical Center
- Investigative Clinical Research Of Indiana, Llc
- Beth Israel Comprehensive Cancer Center
- Dana Farber Cancer Institute.
- Rochester General Hospital
- Carolinas Healthcare System
- Va Pittsburgh Healthcare System
- St Francis Hospital
- Tennessee Cancer Specialists
- Northern Utah Associates
- University Of Washington
- Local Institution
- Local Institution
- CISSS de l'Outaouais
- Local Institution - 0048
- Local Institution - 0022
- Local Institution - 0021
- Local Institution - 0020
- Local Institution - 0019
- Local Institution
- Universitaetsklinikum Carl Gustav Carus
- Universitaetsklinikum Freiburg
- St. Barbara-Klinik
- Local Institution - 0041
- Local Institution - 0056
- Klinikum Der Johannes Gutenberg Universitaet Mainz
- Universitaetsklinikum Tuebingen
- Laiko University Hospital
- Alexandra General Hospital Of Athens
- Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona
- A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
- Azienda Ospedaliera Universitaria Careggi
- Local Institution
- Universita' La Sapienza
- Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino
- Local Institution - 0030
- Local Institution - 0069
- Local Institution - 0031
- Local Institution - 0029
- Local Institution - 0027
- Local Institution - 0028
- Local Institution - 0067
- Local Institution - 0032
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
- Local Institution
- Oddzial Hematologii i Transplantacji Szpiku
- Local Institution
- Local Institution
- Local Institution - 0024
- Local Institution
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Elotuzumab Arm
Control Arm
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
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