Selinexor Treatment of Refractory Myeloma



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:May 2015
End Date:October 2019

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A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low-‑Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) Daratumumab, and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and an the Anti-CD38 mAb Daratumumab

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus
dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with
penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus
dexamethasone 20 mg (Sd), both dosed twice weekly in each four-week cycle, in patients with
MM previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and
daratumumab and refractory to prior treatment with glucocorticoids, an immunomodulatory agent
(IMiD), a proteasome inhibitor (PI), and daratumumab.

This study consists of two parts:

- Part 1 enrolled patients with both quad-refractory MM and penta-refractory MM.

- Part 2 will enroll patients with penta-refractory MM only.

Inclusion Criteria:

Measurable MM based on modified IMWG guidelines. Defined by at least one of the following:

1. Serum M-protein ≥ 0.5 g/dL by serum electrophoresis (SPEP) or for IgA myeloma, by
quantitative IgA

2. Urinary M-protein excretion ≥ 200 mg/24 hours

3. Free Light Chain (FLC) ≥ 100 mg/L, provided that the FLC ratio is abnormal

4. If serum protein electrophoresis is felt to be unreliable for routine M-protein
measurement, then quantitative Ig levels by nephelometry or turbidimetry are
acceptable

- Must have previously received ≥ 3 anti-MM regimens including: an alkylating
agent, lenalidomide, pomalidomide, bortezomib, carfilzomib, daratumumab, and a
glucocorticoid. There is no upper limit on the number of prior therapies provided
that all other inclusion/exclusion criteria are met.

- MM refractory to previous treatment with one or more glucocorticoids, parenteral
PI (i.e., bortezomib and/or carfilzomib), IMiD (i.e., lenalidomide and/or
pomalidomide), and the anti-CD38 mAb, daratumumab. Refractory is defined as ≤ 25%
response to therapy, or progression during therapy or progression within 60 days
after completion of therapy.

Exclusion Criteria:

- Active smoldering MM.

- Active plasma cell leukemia.

- Documented systemic amyloid light chain amyloidosis.

- Active CNS MM.
We found this trial at
31
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Andrew Yee, MD
Phone: 877-789-6100
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Ray Comenzo, MD
Phone: 617-636-6033
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Pallawi Torka, MD
Phone: 877-275-7724
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Moshe Levy, MD
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Rachid Baz, MD
Phone: 888-663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Craig Cole, MD
Phone: 877-536-4243
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30322
Principal Investigator: Ajay Nooka, MD
Phone: 404-778-1868
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Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Carol Huff, MD
Phone: 410-955-8804
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Birmingham, Alabama 35294
Principal Investigator: Luciano Costa, MD
Phone: 800-822-8816
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Boston, Massachusetts 02115
Principal Investigator: Robert Schlossman, MD
Phone: 617-632-3823
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Chapel Hill, North Carolina
Principal Investigator: Sascha Tuchman, MD
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Chicago, Illinois 60637
Principal Investigator: Andrzej Jakubowiak, MD
Phone: 888-824-0200
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1515 Southwest Archer Road
Gainesville, Florida 32608
Principal Investigator: Hemant Murthy, MD
Phone: 352-273-7832
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Hackensack, New Jersey 07601
Principal Investigator: Josh Richter, MD
Phone: 551-996-5834
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Honolulu, Hawaii 96819
Principal Investigator: Jennifer Carney, MD
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Indianapolis, Indiana 46202
Principal Investigator: Rafat Abonour, MD
Phone: 888-600-4822
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Donald MacFarlane, MD, PhD
Phone: 319-356-1616
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Krems,
Principal Investigator: Klaus Podar, MD, Msc, PhD
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Los Angeles, California 90095
Principal Investigator: Gary Schiller, MD
Phone: 888-798-0719
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Louisville, Kentucky 40207
Principal Investigator: Don Stevens, MD
Phone: 502-629-4349
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Miami, Florida 33136
Principal Investigator: James Hoffman, MD
Phone: 305-243-1000
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Nashville, Tennessee 37232
Principal Investigator: Robert Cornell, MD
Phone: 800-811-8480
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New Haven, Connecticut 06510
Principal Investigator: Terry Lynn Parker, MD
Phone: 203-688-4242
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New York, New York 10016
Principal Investigator: David Kaminetzky, MD
Phone: 212-263-4432
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New York, New York 10029
Principal Investigator: Sundar Jagannath, MD
Phone: 212-241-6500
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Dan Vogl, MD
Phone: 800-789-7366
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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2850 Northwest Nicolai Street
Portland, Oregon 97210
Principal Investigator: Abdul Hai Mansoor, MD
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: David Dingli, MD
Phone: 855-776-0015
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Ravi Vij, MD
Phone: 866-867-3627
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Scottsdale, Arizona 85259
Principal Investigator: Keith Stewart, MD
Phone: 855-776-0015
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Seattle, Washington 98104
Principal Investigator: William Bensinger, MD
Phone: 855-922-6237
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