Protocol FRF4998g: An Open-label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DFRF4539A in Patients with Relapsed or Refractory Multiple Myeloma
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with multiple myeloma that has returned after treatment (relapsed) or did not respond to prior treatment (refractory).
The purpose of the study is to test the safety of an experimental drug called DFRF4539A. The study will also determine a safe and tolerated dose, how often the drug should be taken, how well people with myeloma can tolerate the drug, and measure how the body processes the drug at different dose levels. All study participants will receive DFRF4539A; there is no placebo.
DFRF4539A is designed to inhibit the growth of tumors. It contains a monoclonal antibody (a type of protein normally made by the immune system to help defend the body from infection and cancer) linked to a drug that blocks cell growth. DFRF4539A targets a specific maker on the surface of myeloma cells.
There are 2 stages in the study. The first stage (dose-escalation) tests different doses of the study drug. At the beginning of the study, participants will receive a low dose of the drug. If it is well tolerated, the dose will be slowly increased as new people join the study. In the second stage of the study, participants will receive the maximum tolerated dose determined in the first stage.
Participants will receive DFRF4539A via infusion on Day 1 of a 21-day cycle. Participants will receive up to 8 cycles of treatment as long as they do not experience unacceptable side effects and their myeloma does not get worse. Participants who receive 8 cycles of study therapy may be eligible to receive additional cycles of DFRF4539A for up to 1 year if the study physician determines it is appropriate for them.
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Disease Status and/or Stage
Relapsed or Refractory Multiple Myeloma
Sponsor
Genentech
Key Eligibility
- Men and women age 18 and older
- Relapsed or refractory multiple myeloma for which no effective standard therapy exists
- One of the prior therapies must have included a proteasome inhibitor or an immunomodulatory drug
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- The Myeloma Center
- (212) 746-3964
- [email protected]
Protocol ID
FRF4998g
Healthy Volunteers
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
