Teclistamab
DrugParticipants will receive teclistamab.
Other names: JNJ-64007957
NCT Number: NCT04722146
The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
St Vincents Hospital Melbourne, Fitzroy, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive teclistamab.
Other names: JNJ-64007957
Participants will receive daratumumab.
Participants will receive pomalidomide.
Participants will receive lenalidomide.
Participants will receive bortezomib.
Participants will receive nirogacestat.
Time frame: Up to 2 year and 5 months
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Time frame: Up to 2 year and 5 months
Number of participants with AEs by severity will be reported.
Time frame: Up to 2 year and 5 months
Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
Time frame: Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
Time frame: Up to 2 year and 5 months
ORR is defined as the proportion of participants who achieve partial response (PR) or better according to the international myeloma working group (IMWG) 2016 criteria.
Time frame: Up to 2 year and 5 months
VGPR or better response rate is defined as the proportion of participants who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria.
Time frame: Up to 2 year and 5 months
CR or better response rate is defined as the proportion of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.
Time frame: Up to 2 year and 5 months
sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.
Time frame: Up to 2 year and 5 months
Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria.
Time frame: Up to 2 year and 5 months
Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better.
Time frame: Up to 2 year and 5 months
Serum concentrations of teclistamab will be reported.
Time frame: Up to 2 year and 5 months
Serum concentrations of daratumumab will be reported.
Time frame: Up to 2 year and 5 months
Serum concentration of nirogacestat will be reported.
Time frame: Up to 2 year and 5 months
Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.
Time frame: Up to 2 year and 5 months
Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, E and F.
Time frame: Up to 2 year and 5 months
Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F.
Janssen Research & Development, LLC
Industry
A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Acronym: MajesTEC-2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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