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RECRUITINGPhase 4INTERVENTIONAL

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

An Open Label, Multicenter, Phase IV Study of Teclistamab to Evaluate Its Safety in Indian Participants With Relapsed and Refractory Multiple Myeloma Who Have Previously Received at Least 3 Prior Lines of Therapy Including an Immunomodulatory Agent, a Proteasome Inhibitor and an Anti-CD38 Antibody and Have Demonstrated Disease Progression on the Last Therapy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Teclistamab

Teclistamab will be administered subcutaneously.

Locations (12)

M S Ramaiah Medical College and Hospital
Bangalore, India
St. Johns Medical College And Hospital
Bengaluru, India
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, India
Tata Medical Center
Kolkata, India
Tata Memorial Hospital
Mumbai, India
KIMS-Kingsway Hospitals
Nagpur, India
All India Institute of Medical Sciences
New Delhi, India
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, India
Christian Medical College
Ratnagiri Kilminnal, India
Regional Cancer Centre
Thiruvananthapuram, India