Multiple Myeloma Clinical Trial

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

Summary

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.

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Full Description

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

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Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT02954796

Recruitment Status:

Terminated

Sponsor:

Seagen Inc.

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There are 11 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Scottsdale Arizona, 85259, United States
City of Hope National Medical Center
Duarte California, 91010, United States
Winship Cancer Institute / Emory University School of Medicine
Atlanta Georgia, 30322, United States
Holden Comprehensive Cancer Center / University of Iowa
Iowa City Iowa, 52242, United States
Karmanos Cancer Institute / Wayne State University
Detroit Michigan, 48201, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Weill Cornell Medical College
New York New York, 10065, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas Texas, 75246, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT02954796

Recruitment Status:

Terminated

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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