A Phase I randomized, open-label pharmacokinetic comparability study comparing pre- and post-change teclistamab in participants with relapsed/refractory multiple myeloma
- Conditions
- Relapsed/refractory multiple myelomaCancer
- Registration Number
- ISRCTN46766641
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 100
1. Documented diagnosis of multiple myeloma as defined by the criteria below:
1.1. Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria
1.2. Measurable disease at screening as defined by any of the following:
1.2.1. Serum M-protein level greater than or equal to (=)0.5 grams per deciliter (g/dL) (central laboratory); or
1.2.2. Urine M-protein level =200 milligrams (mg)/24 hours (central laboratory) or
1.2.3. Serum immunoglobulin free light chain =10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
2. Received one to three prior lines of antimyeloma therapy, including a minimum of two consecutive cycles each of a PI, lenalidomide, and an anti-CD38 monoclonal antibody (or minimum of six doses if anti-CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line.
3. Documented evidence of progressive disease or failure to achieve a response to the last line of therapy based on the investigator's determination of response by International Myeloma Working Group (IMWG) criteria
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
5. A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study
1. Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy
2. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
3. Received a live, attenuated vaccine within 4 weeks before the first dose of the study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed
4. Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole-brain magnetic resonance imaging (MRI) and lumbar cytology may be required
5. Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method