Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185)



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:6/2/2017
Start Date:October 19, 2015
End Date:July 31, 2021
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III Study of Lenalidomide and Low-dose Dexamethasone With or Without Pembrolizumab (MK3475) in Newly Diagnosed and Treatment naïve Multiple Myeloma (KEYNOTE 185).

The purpose of this study is to compare the efficacy of lenalidomide and low dose
dexamethasone with pembrolizumab (MK-3475) to that of lenalidomide and low dose
dexamethasone without pembrolizumab in terms of progression-free survival (PFS) in
participants with newly diagnosed and treatment-naïve multiple myeloma who are ineligible
for autologous stem cell transplant (Auto-SCT).


Inclusion Criteria:

- Confirmed diagnosis of active multiple myeloma and measurable disease.

- Ineligible to receive treatment with auto-SCT due to age (≥65 years old) or any
significant coexisting medical condition (cardiac, renal, pulmonary or hepatic
dysfunction), likely to have a negative impact on tolerability of auto-SCT.
Participants <65 years of age who refuse auto-SCT are not eligible for this study.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

- Female participants of childbearing potential must have 2 negative urine pregnancy
tests (with a sensitivity of at least 25 Milli-international units/Milliliter) within
10 to 14 days and within 24 hours prior to receiving study medication.

- Female participants of childbearing potential must agree to use adequate
contraception 28 days prior to study start, continuing throughout the study, and for
up to 28 days after the last dose of lenalidomide (or 120 days after the last dose of
pembrolizumab).

- Male participants of childbearing potential must agree to use adequate contraception
from the first dose of study medication, continuing throughout the study, and for up
to 28 days after the last dose of lenalidomide (or 120 days after the last dose of
pembrolizumab).

Exclusion Criteria:

- Has undergone prior allogeneic hematopoetic stem cell transplantation within the last
5 years.

- Has peripheral neuropathy ≥ Grade 2.

- Has a known additional malignancy that is progressing or requires active treatment
within the last 5 years (except for basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or in situ cervical cancer that has undergone potentially
curative therapy).

- Has history of non-infectious pneumonitis that required steroids or current
pneumonitis

- Has received prior therapy with an anti-programmed cell death 1 receptor (anti-PD-1),
anti-programmed death-ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or
anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including
ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation
or checkpoint pathways).

- Has a known Human Immunodeficiency Virus (HIV), or a known, active Hepatitis B (HBV),
or a known, active Hepatitis C (HCV) infection.

- Is unable or unwilling to undergo thromboembolic prophylaxis including, as clinically
indicated, aspirin, Coumadin (warfarin) or low-molecular weight heparin.

- Has lactose intolerance.

- Has an invasive fungal infection.
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