Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183)



Status:Suspended
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/8/2017
Start Date:October 19, 2015
End Date:October 31, 2019

Use our guide to learn which trials are right for you!

A Phase III Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (KEYNOTE 183)

The purpose of this study is to compare the efficacy of pomalidomide and low dose
dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone
without pembrolizumab in terms of Progression-Free Survival (PFS) in participants with
refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2
lines of prior treatment.


Inclusion Criteria:

- Has a confirmed diagnosis of active multiple myeloma and measurable disease

- Must have undergone prior treatment with ≥2 treatment lines of anti-myeloma therapy
and must have failed last line of treatment (refractory to last line of treatment)

- Prior anti-myeloma treatments must have included an immunomodulatory drug (IMiD) AND
proteasome inhibitor alone or in combination and participant must have failed therapy
with an IMiD OR proteasome inhibitor

- Has performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
Performance Scale

- Female participants of childbearing potential must have 2 negative urine human
chorionic gonadotropin tests within 10 to 14 days and within 24 hours prior to
receiving study medication

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

Exclusion Criteria:

- Has had prior anti-myeloma therapy within 2 weeks prior to study start and has not
recovered (i.e., ≤ Grade 1 or at Baseline) from adverse events due to a previously
administered agent

- Has undergone prior allogeneic hematopoetic stem cell transplantation within the last
5 years. (Participants who have had a transplant greater than 5 years ago are eligible
as long as there are no symptoms of Graft versus Host Disease [GVHD]).

- Has received autologous stem cell transplant (auto-SCT) within 12 weeks before the
first infusion or is planning for or is eligible for auto-SCT

- Has received previous therapy with pomalidomide

- 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 a 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),
antiprogrammed 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 costimulation or checkpoint pathways)

- Is pregnant or breast-feeding
We found this trial at
48
sites
Charleston, South Carolina 29412
2424
mi
from 98109
Charleston, SC
Click here to add this to my saved trials
2348
mi
from 98109
Albany, NY
Click here to add this to my saved trials
2178
mi
from 98109
Atlanta, GA
Click here to add this to my saved trials
1026
mi
from 98109
Aurora, CO
Click here to add this to my saved trials
1775
mi
from 98109
Austin, TX
Click here to add this to my saved trials
2485
mi
from 98109
Boston, MA
Click here to add this to my saved trials
1128
mi
from 98109
Chandler, AZ
Click here to add this to my saved trials
Charlotte, North Carolina 28207
2283
mi
from 98109
Charlotte, NC
Click here to add this to my saved trials
2083
mi
from 98109
Chattanooga, TN
Click here to add this to my saved trials
1733
mi
from 98109
Chicago, IL
Click here to add this to my saved trials
1682
mi
from 98109
Dallas, TX
Click here to add this to my saved trials
959
mi
from 98109
Duarte, CA
Click here to add this to my saved trials
2341
mi
from 98109
Durham, NC
Click here to add this to my saved trials
2346
mi
from 98109
Easton, PA
Click here to add this to my saved trials
Elk Grove Village, Illinois 60007
1712
mi
from 98109
Elk Grove Village, IL
Click here to add this to my saved trials
2450
mi
from 98109
Gainesville, FL
Click here to add this to my saved trials
1825
mi
from 98109
Goshen, IN
Click here to add this to my saved trials
1760
mi
from 98109
Hot Springs, AR
Click here to add this to my saved trials
1890
mi
from 98109
Houston, TX
Click here to add this to my saved trials
2449
mi
from 98109
Jacksonville, FL
Click here to add this to my saved trials
1720
mi
from 98109
Joliet, IL
Click here to add this to my saved trials
Kirkland, Quebec
Phone: 514-428-8600 / 1-800-567-2594
2270
mi
from 98109
Kirkland,
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
1616
mi
from 98109
Madison, WI
Click here to add this to my saved trials
2164
mi
from 98109
Marietta, GA
Click here to add this to my saved trials
1723
mi
from 98109
Maywood, IL
Click here to add this to my saved trials
2733
mi
from 98109
Miami Beach, FL
Click here to add this to my saved trials
1681
mi
from 98109
Milwaukee, WI
Click here to add this to my saved trials
762
mi
from 98109
Monterey, CA
Click here to add this to my saved trials
2377
mi
from 98109
Morristown, NJ
Click here to add this to my saved trials
2099
mi
from 98109
New Orleans, LA
Click here to add this to my saved trials
2400
mi
from 98109
New York, NY
Click here to add this to my saved trials
1721
mi
from 98109
Niles, IL
Click here to add this to my saved trials
1523
mi
from 98109
Oklahoma City, OK
Click here to add this to my saved trials
1366
mi
from 98109
Omaha, NE
Click here to add this to my saved trials
2132
mi
from 98109
Pittsburgh, PA
Click here to add this to my saved trials
701
mi
from 98109
Salt Lake City, UT
Click here to add this to my saved trials
1790
mi
from 98109
San Antonio, TX
Click here to add this to my saved trials
681
mi
from 98109
San Francisco, CA
Click here to add this to my saved trials
635
mi
from 98109
Santa Rosa, CA
Click here to add this to my saved trials
1723
mi
from 98109
Skokie, IL
Click here to add this to my saved trials
299
mi
from 98109
Springfield, OR
Click here to add this to my saved trials
2231
mi
from 98109
Syracuse, NY
Click here to add this to my saved trials
26
mi
from 98109
Tacoma, WA
Click here to add this to my saved trials
2527
mi
from 98109
Tampa, FL
Click here to add this to my saved trials
1762
mi
from 98109
Tyler, TX
Click here to add this to my saved trials
139
mi
from 98109
Vancouver, WA
Click here to add this to my saved trials
111
mi
from 98109
Yakima, WA
Click here to add this to my saved trials