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New treatment option for Hematological Malignancies
Official title A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT04634552
What this study is testing
What is Talquetamab?
Talquetamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hematological malignancies.
Also referred to as JNJ-64407564.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
- Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive...
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
You likely can't join if
- Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell...
- Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral...
- Received a cumulative dose of corticosteroids equivalent to \>= 140 milligram (mg) of prednisone within the 14-day period before the first dose of...
- Stroke or seizure within 6 months prior to signing the informed consent form (ICF)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Duarte, California, United States
- Hollywood, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Rochester, New York, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Edegem, Belgium
- Leuven, Belgium
- Liège, Belgium
- Woluwe-Saint-Lambert, Belgium
- Beijing, China
- Guangzhou, China
- Hangzhou, China
+ 48 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Duarte, California, United States; Hollywood, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 62 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.