IRB #

STUDY00018388

Title

[NCI CIRB] S1702, A Phase II Study of Isatuximab (SAR650984) for Patients with Previously Treated AL Amyloidosis

Principal Investigator

Eva Medvedova

Study Purpose

The purpose of this study is to test for any good and bad effects of the study drug called isatuximab. Isatuximab is not approved by the Food and Drug Administration (FDA). Isatuximab has been shown to have good effects in some patients with recurring multiple myeloma. For this reason, the researchers think that isatuximab may also help patients whose amyloidosis has recurred or gotten worse. To decide if the study treatment is better than the usual approach, the study doctors will be looking to see if the study treatment increases the number of patients whose cancer responds to treatment by at least 30 percent.

Medical Condition(s)

Previously treated AL Amyloidosis

Eligibility Criteria

- Men and women at least 18 years of age
- You must have relapsed or refractory primary systemic AL Amyloidosis
- You must be relapsed or refractory to at least one prior line of therapy

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drug for up to two years, or until your disease gets worse, you have unacceptable side effects from the study drug, or you or your investigator choose to stop the therapy for another reason. After you finish taking the study drug, your doctor will continue to watch you for side effects and follow your condition. For this reason, you will have a study visit every 6 months for 2 more years or until your disease get worse. After your disease gets worse, your doctor will continue to watch you as is appropriate standard of care for your disease.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

SWOG

Recruitment End

06/01/2022

Compensation Provided

No


Go Back