Status:
WITHDRAWN
An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research study is studying a combination of targeted therapies as a possible treatment for multiple myeloma (MM). The drugs involved in this study are: * Elotuzumab * Nivolumab * Pomalidomide *...
Detailed Description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the combination works in treating a...
Eligibility Criteria
Inclusion
- Male or female patient ≥ age 18 years
- Patient is able to understand and has given voluntary written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
- Patient has been previously diagnosed with MM based on standard International Myeloma Working Group (IMWG) criteria and currently requires treatment.
- Patient must have received at least two previous lines of therapy for multiple myeloma including lenalidomide or thalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib).
- Patient must have demonstrated disease progression on or within 60 days of completion of the last therapy. Patient has measurable disease defined as at least one of the following:
- Serum M protein ≥ 0.5 g/dL (≥5 g/L)
- Urine M protein ≥200 mg/24 hours
- Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Appendix A)
- Negative serum or urine pregnancy test for women of child-bearing potential
- Screening Laboratory parameters:
- Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L). Granulocyte colony-stimulating factor (GCSF) is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
- Platelet count ≥ 75,000 cells/dL (75 x 109/L) Platelet transfusion is not permitted during screening to meet eligibility criteria and within 14 days of initiation of therapy
- Hemoglobin ≥ 8.0 g/dl ( red blood cell (RBC) transfusions are permitted during the screening period)
- Total Bilirubin ≤ 1.5 X upper limit of normal (ULN) (Patients with known Gilbert Syndrome are allowed to have total bilirubin \< 3.0 mg/dL)
- Aspartate transaminase (AST, or SGOT) and alanine transaminase (ALT, or SGPT) ≤ 3.0x ULN
- Estimated creatinine clearance by Cockcroft-Gault formula ≥ 40 mL/min
- Serum creatinine \< 1.5 X ULN. (Appendix C)
Exclusion
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy.
- Prior therapy with pomalidomide
- Prior treatment with monoclonal antibodies including elotuzumab
- Prior therapy with anti-programmed death 1 (PD-1) or programmed death-ligand 1 (PD-L1) agents.
- Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
- Prior anti-cancer therapy within 14 days.
- Patient has any Grade 3 or \> unresolved adverse reaction from previous treatment. Previous allogeneic stem cell transplantation with active graft-versus-host disease (GVHD) or being under immunosuppressive therapy in the last 2 months prior to inclusion in the trial.
- Autologous stem cell transplant if \< 12 weeks from enrollment.
- Daily requirement for oral corticosteroids (equivalent to \> 10 mg/day prednisone daily) Inhaled or topical corticosteroids are allowed.
- Patient is human immunodeficiency virus (HIV) positive,.
- Patient is Hepatitis B Surface antigen-positive.
- Patient has active hepatitis C infection.
- Patient has an autoimmune disease. (Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger).
- Any clinically significant, uncontrolled medical conditions that, in the treating Investigator's opinion, would impose excessive risk to the patient or may interfere with compliance or interpretation of the study results. Uncontrolled intercurrent illness may include, but is not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations as determined by treating investigator that would limit compliance with study requirements.
- History of erythema multiforme or severe hypersensitivity to prior IMiD's®
- Inability to tolerate thromboprophylaxis
- Known severe intolerance to prior steroid therapy (Grade 3 or above adverse event which was unresponsive to a dose reduction)
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03227432
Start Date
December 1 2018
End Date
December 31 2024
Last Update
August 14 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115