1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-30

Study Completion Date

2017-08-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pomalidomide, Dexamethasone & MK-3475

Pomalidomide 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).

Group Type EXPERIMENTAL

MK-3475

Intervention Type DRUG

Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.

Pomalidomide

Intervention Type DRUG

Pomalidomide is given at standard dose of 4 mg daily orally for 21 days

Dexamethasone

Intervention Type DRUG

Dexamethasone is given at 40 mg orally weekly

Interventions

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MK-3475

Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.

Intervention Type DRUG

Pomalidomide

Pomalidomide is given at standard dose of 4 mg daily orally for 21 days

Intervention Type DRUG

Dexamethasone

Dexamethasone is given at 40 mg orally weekly

Intervention Type DRUG

Other Intervention Names

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Generic name: Pembrolizumab - Trade name: Keytruda Pomalyst, CC-4047, Actimid Decadron

Eligibility Criteria

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Inclusion Criteria

1. Confirmed diagnosis of relapsed and/or refractory MM according to International Myeloma Working Group guidelines (2003)
2. 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.
3. Measureable disease as defined by the protocol (assessed within 28 days prior to registration).
4. Be willing and able to provide written informed consent/assent for the trial.
5. Be over 18 years of age on day of signing informed consent.
6. Have a performance status of 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. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or situ cervical cancer that has undergone potentially curative therapy.
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.
11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
12. Pregnant or breastfeeding, or expecting to conceive or father children during study participation.
13. 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.
14. has known active Hepatitis B or Hepatitis C.
15. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
16. Has received a live vaccine within 30 days prior to the first dose of trial treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No