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

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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
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