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Trial record 3 of 496 for:    Recruiting, Not yet recruiting, Available Studies | "Multiple Myeloma"

An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03227432
Recruitment Status : Not yet recruiting
First Posted : July 24, 2017
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Jacob Laubach, Dana-Farber Cancer Institute

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
  • Dexamethasone

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Dexamethasone Drug: Pomalidomide Drug: Elotuzumab Drug: Nivolumab Phase 2

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 specific disease. "Investigational" means that the drug combination is being studied.

This study has two parts. Each part tests a different combination of drugs.

  • In Part 1 participants will be given elotuzumab and nivolumab.
  • In Part 2 participants will be given elotuzumab, nivolumab, pomalidomide, and dexamethasone.

Each of these drugs works in a different way to help the body fight multiple myeloma. The drugs are being tested in different combinations to see if they are more effective when taken together.

Elotuzumab is an antibody, that stimulates the immune system to fight your disease. The FDA (the U.S. Food and Drug Administration) has approved elotuzumab in combination with lenalidomide as a treatment option for this disease.

In this research study, the participant will receive pomalidomide which is an immunomodulatory drug. This means that pomalidomide modulates the immune system to help fight the disease. The FDA has approved pomalidomide as a treatment option for this disease after receiving two other therapies.

Dexamethasone, also FDA approved, is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers, such as myeloma and leukemias.

The FDA has not approved nivolumab for this specific disease but it has been approved for other uses, specifically lung cancer. Nivolumab works by blocking an inhibitory signal within immune cells, potentially allowing the immune system to fight the cancer.

In this research study the investigators are looking to see if the combination of elotuzumab, nivolumab, pomalidomide, and dexamethasone is effective in fighting the cancer.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study to Evaluate the Combination of Elotuzumab and Nivolumab With and Without Pomalidomide in Relapsed Refractory Multiple Myeloma
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Experimental: Nivolumab + Elotuzumab
  • 22 patients will be entered, If > 4 patients achieve at least a partial response (PR) within 4 cycles an additional 18 patients will be treated.
  • Nivolumab will be administered intravenously twice per cycle for cycle 1-4
  • Nivolumab will be administered intravenously once per cycle for cycle 5
  • Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2
  • Elotuzumab will be administered intravenously twice per cycle for cycle 3-4
  • Elotuzumab will be administered intravenously once per cycle for cycle 5
Drug: Elotuzumab
Elotuzumab is an antibody, that stimulates the immune system to fight diseases
Other Name: Empliciti

Drug: Nivolumab
Nivolumab works by blocking an inhibitory signal within immune cells, potentially allowing the immune system to fight the cancer
Other Name: Opdivo

Experimental: Nivolumab+Elotuzumab+Pomalidomide+Dexamethasone
  • Nivolumab will be administered intravenously twice per cycle for cycle 1-4
  • Nivolumab will be administered intravenously once per cycle for cycle 5
  • Elotuzumab will be administered intravenously 4 times per cycle for cycle 1-2
  • Elotuzumab will be administered intravenously twice per cycle for cycle 3-4
  • Elotuzumab will be administered intravenously once per cycle for cycle 5
  • Pomalidomide will be administered for 21 days per cycle
  • Dexamethasone will be administered weekly
Drug: Dexamethasone
Dexamethasone, a corticosteroid, is similar to a natural hormone produced by adrenal glands. It relieves inflammation.
Other Name: Maxidex

Drug: Pomalidomide
Pomalidomide which is an immunomodulatory drug. This means that pomalidomide modulates the immune system to help fight diseases.
Other Name: Pomalyst

Drug: Elotuzumab
Elotuzumab is an antibody, that stimulates the immune system to fight diseases
Other Name: Empliciti

Drug: Nivolumab
Nivolumab works by blocking an inhibitory signal within immune cells, potentially allowing the immune system to fight the cancer
Other Name: Opdivo




Primary Outcome Measures :
  1. Response Rate [ Time Frame: 2 years ]
  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The Rate of Clinical Benefit Response (CBR) [ Time Frame: 2 years ]
  2. Time to Response [ Time Frame: 2 years ]
  3. Duration of Response [ Time Frame: 2 years ]
  4. Progression Free Survival [ Time Frame: 2 years ]
  5. Overall Survival [ Time Frame: 2 years ]
  6. Time to Treatment Failure [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227432


Contacts
Contact: Jacob Laubach, MD 617-582-7102 JacobP_Laubach@dfci.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Andrew Yee, MD    617-726-6801      
Principal Investigator: Andrew Yee, MD         
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Jacalyn Rosenblatt, MD    617-667-9920      
Principal Investigator: Jacalyn Rosenblatt, MD         
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Jacob Laubach, MD    617-582-7102    JacobP_Laubach@dfci.harvard.edu   
Principal Investigator: Jacob Laubach, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Bristol-Myers Squibb
Investigators
Principal Investigator: Jacob Laubach, MD Dana-Farber Cancer Institute

Responsible Party: Jacob Laubach, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03227432     History of Changes
Other Study ID Numbers: 16-645
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacob Laubach, Dana-Farber Cancer Institute:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Nivolumab
Pomalidomide
Thalidomide
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists