Study on Teclistamab for Patients with Relapsed or Hard-to-Treat Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
Sponsor score: 60
ClinicalTrials ID:NCT04557098
This clinical trial is testing the effectiveness of a drug called teclistamab in patients with multiple myeloma that has returned or is not responding to treatment. The study aims to determine how well the drug works at a specific dose.
Patient Parameters
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Program Overview
The purpose of this study is to find out how effective the drug teclistamab is for treating patients with multiple myeloma that has come back or is difficult to treat. Researchers are testing the drug at a dose that has been recommended for further study.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of multiple myeloma based on specific medical criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have measurable multiple myeloma as determined by lab tests.
- Women who can become pregnant must have a negative pregnancy test before starting the study.
- Be willing and able to follow the study rules and restrictions.
- For Cohort A: Have received at least 3 previous treatments, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
- For Cohort C: Have received at least 3 previous treatments, including a PI, an IMiD, an anti-CD38 antibody, and an anti-BCMA treatment (such as CAR-T cells or an antibody drug conjugate).
Exclusion Criteria
- Have certain other blood disorders like plasma cell leukemia or Waldenström's macroglobulinemia.
- Have serious medical conditions such as needing oxygen for lung problems, HIV, hepatitis B or C, recent stroke or seizure, autoimmune diseases, uncontrolled infections, or severe heart problems.
- Have received any BCMA-targeted therapy, except for those in Cohort C.
- Have had recent cancer treatments, including certain drugs or radiation, within a specified time before starting the study.
- Have unresolved side effects from previous cancer treatments, except for hair loss or mild nerve damage.
- Have taken a high dose of steroids recently.
- Have active cancer in the central nervous system or signs of cancer in the brain or spinal cord.
- Have other active cancers, except for certain types that are considered cured or have a low risk of coming back.
- Have had a stem cell transplant recently (within 6 months for allogenic or 12 weeks for autologous).
- Have received a live vaccine within 4 weeks before starting teclistamab.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294 | Birmingham | Alabama |
| City of Hope | 91010 | Duarte | California |
| University of California San Francisco | 94143 | San Francisco | California |
| Stanford University Medical Center | 94305-5623 | Stanford | California |
| Winship Cancer Institute Emory University | 30322 | Atlanta | Georgia |
| Barbara Ann Karmanos Cancer Institute | 48201 | Detroit | Michigan |
| Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects | 10029 | New York | New York |
| Memorial Sloan-Kettering Cancer Center | 10065 | New York | New York |
| Levine Cancer Institute | 28204 | Charlotte | North Carolina |
| University of Pennsylvania | 19104 | Philadelphia | Pennsylvania |
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