Study on TNB-383B for Patients with Relapsed or Hard-to-Treat Multiple Myeloma
Sponsor: AbbVie
ClinicalTrials ID:NCT03933735
This clinical trial is testing a new treatment called TNB-383B for patients with multiple myeloma that has returned or not responded to previous treatments. The study aims to evaluate the safety and effectiveness of this treatment in different dosing schedules.
Patient Parameters
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Program Overview
This study is exploring a new treatment, TNB-383B, for patients with multiple myeloma that has come back or is difficult to treat. The trial is in its early stages and aims to find out how safe and effective TNB-383B is when given alone in different doses and schedules. Participants will receive the treatment every three or four weeks, and researchers will monitor how well they tolerate it and how it affects their cancer.
Eligibility Criteria
Inclusion Criteria
- Have received at least three previous treatments for multiple myeloma, including specific types of drugs.
- Have good bone marrow function as per study guidelines.
- Have a kidney function level of at least 30 mL/min.
- Have normal or near-normal bilirubin levels, unless diagnosed with Gilbert's syndrome.
- Have normal calcium levels in the blood.
- Have measurable disease, such as specific levels of M-protein in blood or urine, or abnormal free light chain levels.
- Show signs of the disease returning or not responding to the last treatment.
- Agree to provide a recent bone marrow sample or have a suitable sample from the last six months.
Exclusion Criteria
- Have been diagnosed or treated for another cancer within the last three years, except for certain skin cancers or low-risk prostate cancer.
- Have a history of myeloma affecting the brain or nerves.
- Have severe nerve damage.
- Have certain rare conditions like plasma cell leukemia or amyloidosis.
- Have taken another experimental drug recently.
- Have had a stem cell transplant too recently.
- Have any medical or mental health condition that could increase risks or affect the study.
- Have had recent cancer treatment or major surgery.
- Have an active infection needing treatment.
- Have a history of major heart problems.
- Have unresolved side effects from previous treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Francisco (UCSF) - Parnassus Heights /ID# 238680 | 94143 | San Francisco | California |
| Tulane University School of Medicine /ID# 242322 | 70112 | New Orleans | Louisiana |
| Mayo Clinic - Rochester /ID# 238683 | 55905-0001 | Rochester | Minnesota |
| Washington University-School of Medicine /ID# 238681 | 63110 | St Louis | Missouri |
| Mt Sinai /ID# 242317 | 10029-6542 | New York | New York |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244831 | 10065-6007 | New York | New York |
| University of North Carolina /ID# 238685 | 27514 | Chapel Hill | North Carolina |
| Atrium Health Levine Cancer Institute /ID# 238786 | 28204 | Charlotte | North Carolina |
| Atrium Health Wake Forest Baptist Medical Center /ID# 238787 | 27157 | Winston-Salem | North Carolina |
| Wisconsin Medical Center /ID# 238684 | 53226 | Milwaukee | Wisconsin |
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