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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohnson & Johnson Private Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Teclistamab

    Drug

    Teclistamab will be administered subcutaneously.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: TeclistamabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-Emergent Adverse Events (TEAE)s

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.

Time frame
Up to approximately 2 years 1 month

Secondary outcomes

1

Overall Response Rate (ORR)

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.

Time frame
Up to approximately 2 years 1 month
2

Percentage of Participants With Best Response of Very Good Partial Response (VGPR) or Better

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.

Time frame
Up to approximately 2 years 1 month

Other outcomes

Sponsors and contacts

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