Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to assess the safety of teclistamab in routine clinical practice when given as monotherapy in Indian participants with relapsed and refractory multiple myeloma (RRMM) (that is, a blood cancer that comes back after treatment or does not respond to treatment) who have previously received at least 3 prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-cluster of differentiation (CD)38 antibody (is a protein that fights infection) and whose disease have progressed on the last therapy.
Interventions
DRUGTeclistamab
Teclistamab will be administered subcutaneously.
Sponsors
Johnson & Johnson Private Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant with diagnosed RRMM (as per IMWG definitions or investigator's discretion) who have received at least 3 prior lines of therapy including a proteasome inhibitor, an anti-CD 38 antibody and an immunomodulatory agent and have demonstrated disease progression on the last therapy * Documented evidence of progressive disease on last line of therapy based on investigator's determination of response by IMWG response criteria * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and not a woman of child bearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than \[\<\] 1 percent \[%\] per year), preferably with low user dependency, during the treatment period and for a period of 6 months after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during study period * A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study treatment
Exclusion criteria
* Participants who are not eligible to receive teclistamab as per the locally approved prescribing information * Received any prior B cell maturation antigen (BCMA)-directed therapy * Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI, and lumbar cytology are required * Stroke, transient ischemic attack, or seizure within 6 months prior to screening * Participant had major surgery or had significant traumatic injury within 2 weeks prior to enrollment, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAE)s | Up to approximately 2 years 1 month | An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are AEs with onset during the treatment or that are a consequence of a preexisting condition that has worsened since the first dose of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any AE that is considered treatment-related regardless of the start date of the event. TEAEs reported will include all serious and non-serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to approximately 2 years 1 month | ORR is defined as the percentage of participants who have a response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) or better per investigator assessment according to the International Myeloma Working Group (IMWG) response criteria. |
| Percentage of Participants With Best Response of Very Good Partial Response (VGPR) or Better | Up to approximately 2 years 1 month | VGPR or better response rate is defined as the percentage of participants who achieve a response of VGPR or better response (sCR, CR and VGPR) as per investigator assessment according to the IMWG response criteria. |
Countries
India
Contacts
STUDY_DIRECTORJohnson & Johnson Private Limited Clinical Trial
Johnson & Johnson Private Limited
Outcome results
None listed