Study Stopped
Due to the inclusion of an IMid in combination with pembrolizumab, Study Sponsor terminated the study.
1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma
1454GCC: Phase I/II Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 multiple-myeloma
Started Dec 2014
Shorter than P25 for phase_1 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedStudy Start
First participant enrolled
December 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2017
CompletedResults Posted
Study results publicly available
August 1, 2018
CompletedNovember 5, 2019
November 1, 2019
2.6 years
October 17, 2014
February 12, 2018
November 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Participants With Adverse Events
Establish the safety and tolerability of Pomalidomide and Dexamethasone in combination with MK-3475
24 month
Secondary Outcomes (2)
PD-LI Expression On Myeloma Cells
Tissue sample collection will take place before starting study therapy with MK-3475 at baseline and again at time of relapse as defined by the International Myeloma Working Group Response Criteria (Average of up to 24months)
Time to Progression Free Survival (PFS)
PFS assessments will take place after starting study therapy with MD-3475 and will continue until the start of a new anti-neoplastic therapy, disease progression, death, or the end of study up to an average of 24 months.
Study Arms (1)
Pomalidomide, Dexamethasone & MK-3475
EXPERIMENTALPomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
Interventions
Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days
Dexamethasone is given at 40 mg orally weekly
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of relapsed and/or refractory MM according to International Myeloma Working Group guidelines (2003)
- Received two 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). (a). Prior pomalidomide therapy is permitted, provided the patient achieved at least a partial remission and had not progressed for 3 months after stopping therapy.
- Measureable disease as defined by the protocol (assessed within 28 days prior to registration).
- Be willing and able to provide written informed consent/assent for the trial.
- Be over 18 years of age on day of signing informed consent.
- Have a performance status of 2 on the ECOG Performance Scale.
- Demonstrate adequate organ function as defined by the protocol.
- Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study drug.
- Male subjects should agree to use an adequate method of contraception.
You may not qualify if:
- 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.
- 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.
- 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.
- 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.)
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or situ cervical cancer that has undergone potentially curative therapy.
- Has known active central nervous system disease and/or carcinomatous meningitis.
- 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.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- 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.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Pregnant or breastfeeding, or expecting to conceive or father children during study participation.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody as per the protocol.
- has known active Hepatitis B or Hepatitis C.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ashraf Badroslead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201-1592, United States
Related Publications (1)
Badros A, Hyjek E, Ma N, Lesokhin A, Dogan A, Rapoport AP, Kocoglu M, Lederer E, Philip S, Milliron T, Dell C, Goloubeva O, Singh Z. Pembrolizumab, pomalidomide, and low-dose dexamethasone for relapsed/refractory multiple myeloma. Blood. 2017 Sep 7;130(10):1189-1197. doi: 10.1182/blood-2017-03-775122. Epub 2017 May 1.
PMID: 28461396DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ashraf Badros M.B.Ch.B
- Organization
- University of Maryland Greenebaum Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ashraf Z Badros, M.B.,Ch.B
University of Maryland Greenebaum Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
October 17, 2014
First Posted
November 13, 2014
Study Start
December 30, 2014
Primary Completion
August 7, 2017
Study Completion
August 7, 2017
Last Updated
November 5, 2019
Results First Posted
August 1, 2018
Record last verified: 2019-11