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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Participants will receive teclistamab.
Participants will receive daratumumab.
Participants will receive pomalidomide.
Number of Participants with Incidence of Adverse Events (AEs)
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
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
Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
Time frame: Up to 2 year and 5 months
Number of Participants with Dose-Limiting Toxicity (DLT)
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 Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)
Overall Response Rate (ORR)
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
Very Good Partial Response (VGPR) or Better Response Rate
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.
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Participants will receive lenalidomide.
Participants will receive bortezomib.
Participants will receive nirogacestat.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
...and 17 more locations
Time frame: Up to 2 year and 5 months
Complete Response (CR) or Better Response Rate
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
Stringent Complete Response (sCR) Rate
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
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
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
Serum concentrations of teclistamab will be reported.
Time frame: Up to 2 year and 5 months
Serum Concentrations of Daratumumab
Serum concentrations of daratumumab will be reported.
Time frame: Up to 2 year and 5 months
Serum Concentrations of Nirogacestat
Serum concentration of nirogacestat will be reported.
Time frame: Up to 2 year and 5 months
Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab
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 Presence of Anti-Drug Antibodies to Daratumumab
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 Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F.
Time frame: Up to 2 year and 5 months