Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Relapsed/Refractory, MK-3475 & Pomalidomide, Immunotherapy
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: MK-3475 Type: Drug
Name: Pomalidomide Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
Summary
This is an open label trial of Anti PD1/MD-3475, Pomalidomide and dexamethasone. The study will use standard (FDA approved) doses for both pomalidomide and dexamethasone. The experimental drug Anti PD-1 (MK 3475) given on days 1 and 14.
Detailed Description
This phase I/II study is focused on patients with relapsed or refractory multiple myeloma. MK-3475 will be given as an intravenous infusion at every 2 weeks. Treatment will be administered on an outpatient basis.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Confirmed diagnosis of relapsed and/or refractory MM according to International Myeloma Working Group guidelines (2003)

2. Documented disease progression during or within 60 days after their most recent line of anti-myeloma therapy.

3. Failure of 2 lines of prior therapy that includes an IMiD (lenalidomide or thalidomide) and a Proteasome inhibitor (bortezomib and/or carfilzomib) (used either separately or in combination).

4. Measurable disease as defined by the protocol.

5. Be willing and able to provide written informed consent/assent for the trial.

6. Have a performance status of 0 1 2 on the ECOG Performance Scale.

7. Demonstrate adequate organ function as defined by the protocol.

8. Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study drug.

9. Male subjects should agree to use an adequate method of contraception.

Exclusion Criteria:

1. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.

2. Has a diagnosis of immunodeficiency (HIV) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.

3. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.

4. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. (Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.)

5. Has a known additional malignancy that is progressing or requires active treatment.

6. Has known active central nervous system disease and/or carcinomatous meningitis.

7. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.

8. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.

9. Has an active infection requiring systemic therapy.

10. Has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Location
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Status: Recruiting
Contact: Sunita Philip, MPH - 410-328-8199 - sphilip1@umm.edu
Start Date
December 2014
Completion Date
December 2016
Sponsors
Ashraf Badros
Source
University of Maryland
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page