A Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:December 2016
End Date:December 2019

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Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma

This study tests the safety of a drug called SGN-CD352A, to find out what its side effects
are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple
myeloma.

The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given
to different patients (each individual patient will get the same dose for all treatments).
The doses will be very low at the start of the trial, and will increase only when the lower
dose levels are proven safe.

In the second part of the study, up to 2 dose levels that are both safe and show promising
activity against MM will be given to more patients

Inclusion Criteria:

- Diagnosis of MM requiring systemic therapy (per the International Myeloma Working
Group [IMWG] ).

- Age 18 years or older.

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

- Life expectancy greater than 3 months.

- Received at least 2 prior lines of therapy for MM including an immunomodulatory drug
and a proteasome inhibitor.

- Measurable disease, as defined by at least one of the following: Serum M protein 0.5
g/dL or higher, Urine M protein 200 mg/24 hr or higher, Serum free light chain (SFLC)
10 mg/dL or higher, and Abnormal SFLC ratio.

- Adequate hematologic, renal, and hepatic function

- A negative pregnancy test (for females of childbearing potential).

- Patients must provide written informed consent.

Exclusion Criteria:

- Other invasive malignancy within the past 3 years.

- Active cerebral/meningeal disease related to the underlying malignancy.

- Active Grade 3 or higher infection.

- Known to be positive for HIV or known to have active hepatitis B or C.

- Previous allogeneic stem cell transplant.

- Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for
carbon monoxide (DLCO).

- Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6
months.

- Females who are pregnant or breastfeeding.
We found this trial at
11
sites
Detroit, Michigan
Principal Investigator: Abhinav Deol
Phone: 313-576-9381
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200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Principal Investigator: Yogesh Jethava
Phone: 319-467-5836
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Damian Green, MD
Phone: 206-667-5010
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Seattle, WA
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Atlanta, Georgia 30322
Principal Investigator: Jonathan Kaufman, MD
Phone: 404-778-1900
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Atlanta, GA
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Dallas, Texas 75246
Principal Investigator: Christopher Maisel, MD
Phone: 214-820-8471
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Amrita Krishnan
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, CA
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: David Siegel
Phone: 551-996-8020
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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New York, New York 10021
Principal Investigator: Ruben Niesvizky, MD
Phone: 646-962-9338
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New York, NY
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Mark Schroeder, MD
Phone: 314-747-2740
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Principal Investigator: Keith Stewart, MD
Phone: 855-776-0015
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Seattle, Washington 98104
Principal Investigator: William Bensinger
Phone: 206-386-6000
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Seattle, WA
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