Researchers are looking for new ways to treat polycythemia vera (PV). People with PV may receive treatment to lower the number of red blood cells in the blood, but the usual treatments may not work for everyone. Researchers want to learn if a trial medicine called bomedemstat, also called MK-3543, can treat PV. In this study, researchers will compare bomedemstat to 2 usual treatments for PV. The goal of this study is to learn if more participants who take bomedemstat reach healthy blood cell counts and avoid major health problems from PV, compared to those who receive a usual treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
Oral Capsule
Oral Tablet
Subcutaneous Solution
Clinicohematologic Response (CHR) Rate
CHR Rate is defined as all of the following: (i) a confirmed hematologic remission sustained for at least 12 consecutive weeks by Week 40 through Week 52, (ii) and absence of any of the following as assessed by the adjudication committee Week 52: thrombotic event; major hemorrhagic events; disease progression to myelofibrosis (MF) or myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML). CHR will begin on the date of the first confirmed assessment achieving CHR criteria and will end on the earliest date of the following: 1) day of the first confirmed assessment not achieving CHR criteria, 2) date of first major hemorrhagic event or thrombotic event as assessed by the adjudication committee, or 3) disease progression as assessed by the adjudication committee. The CHR rate will be presented.
Time frame: Up to approximately Week 52
Clinicohematologic Response Sustained for a 24-Week Time Period (CHR24)
CHR24 is defined as all of the following: (i) a confirmed hematologic remission sustained for at least 24 consecutive weeks by Week 52, (ii) and absence of any of the following as assessed by the adjudication committee Week 52: thrombotic event; major hemorrhagic events; disease progression to MF or MDS/AML. CHR24 will begin on the date of the first confirmed assessment achieving CHR24 criteria and will end on the earliest date of the following: 1) day of the first confirmed assessment not achieving CHR24 criteria, 2) date of first major hemorrhagic event or thrombotic event as assessed by the adjudication committee, or 3) disease progression as assessed by the adjudication committee. The CHR24 will be presented.
Time frame: Up to approximately Week 52
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.
Time frame: Up to approximately Week 52
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately Week 52
Duration of Clinicohematologic Response Sustained for a 24-Week Time Period (DOCHR24)
For participants who show CHR24, DOCHR24 is defined as the time from the first confirmed hematologic remission to first documented evidence of: 1) confirmed platelet increase, confirmed WBC increase, or a required phlebotomy (defined as a confirmed HCT reduction) after latest confirmed hematologic remission date, 2) thrombotic event as assessed by the adjudication committee, 3) major hemorrhagic event as assessed by the adjudication committee, or 4) disease progression to MF or MDS/AML as assessed by the adjudication committee.
Time frame: Up to approximately Week 52
Duration of Clinicohematologic Response (DOCHR)
For participants who show CHR, DOCHR is defined as the time from the first confirmed hematologic remission to first documented evidence of: 1) confirmed platelet increase, confirmed WBC increase, or a required phlebotomy (defined as a confirmed HCT reduction) after latest confirmed hematologic remission date, 2) thrombotic event as assessed by the adjudication committee, 3) major hemorrhagic event as assessed by the adjudication committee, or 4) disease progression to MF or MDS/AML as assessed by the adjudication committee.
Time frame: Up to approximately Week 52
Duration of Hematologic Remission (DOHR)
For participants who show confirmed hematologic remission, DOHR is defined as the time from the first hematologic remission until loss of hematologic remission.
Time frame: Up to approximately Week 52
Number of Participants Who Experience Phlebotomies
Per protocol, a required phlebotomy is defined as confirmed hematocrit (HCT) ≥45% with a ≥3% increase from baseline HCT or confirmed HCT ≥48%. The number of participants who experienced phlebotomies will be presented.
Time frame: Up to approximately Week 52
Disease Progression Rate
Disease progression is defined as the transformation to post polycythemia vera myelofibrosis, myelodysplastic syndrome, or acute myeloid leukemia as assessed by the adjudication committee. The disease progression rate will be presented.
Time frame: Up to approximately Week 52
Number of Participants Who Experience Thrombotic Events
Thrombotic events are defined as new or recurrent acute myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), deep venous thrombosis (DVT), pulmonary embolism (PE), thrombotic digital ischemia, other thrombotic events such as peripheral limb ischemia or Budd-Chiari syndrome assessed to be due to underlying polycythemia vera (PV), and other vascular occlusive events such as symptoms of cardiac, abdominal, or peripheral limb ischemia supported by objective evidence of vessel disease and/or ischemia. The number of participants who experience thrombotic events will be presented.
Time frame: Up to approximately Week 52
Number of Participants Who Experience Major Hemorrhagic Events
Major hemorrhagic events include but are not limited to fatal bleeding, symptomatic bleeding in a critical area or organ (including intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or bleeding causing a decrease in hemoglobin of 2 g/dL or more or leading to transfusion of 2 or more units of whole blood or red cells, and clinically relevant non-major bleeding events leading to hospitalization or increased level of care or clinically important bleeding prompting a face-to-face medical evaluation.
Time frame: Up to approximately Week 52
Change From Baseline in Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4) Total Symptom Score
The MFSAF v4.0 is a 7-item participant-reported symptom assessment that asks respondents to report symptom severity at its worst for each of the 7 items on a 0 (Absent) to 10 (Worst Imaginable) numeric rating scale. The MFSAF v4.0 7-day recall format is used. Individual symptoms are assessed on an 11-point numeric rating scale with a total symptom score range of 0 (absent) to 70 (worst imaginable). The change from baseline in MFSAF total score for all symptoms will be presented
Time frame: Up to approximately Week 52
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a Total Fatigue Score
The PROMIS Fatigue SF is a 7-item participant-reported assessment that measures both the experience of fatigue and the interference of fatigue on daily activities over the past week. Response options are on a 5-point Likert scale, ranging from 1 (never) to 5 (always). A total score is obtained by summing the responses to the seven items \[range 7 (never) to 35 (always)\] and converting to a standardized T-score. The change from baseline in PROMIS Fatigue SF-7a Total Fatigue Score will be presented.
Time frame: Up to approximately Week 52
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