A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma

Johnson & Johnson (J&J)

Status and phase

Enrolling

Phase 4

Conditions

Multiple Myeloma

Treatments

Drug: Teclistamab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07030517

64007957MMY4007 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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