Teclistamab (IV): Participants will receive IV infusion of Teclistamab.
Teclistamab(SC): Participants will receive SC injection of Teclistamab.
Study summary
The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
* Measurable multiple myeloma that is relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma or be intolerant of those established multiple myeloma therapies, and a candidate for Teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory drug and anti-CD38 monoclonal antibody in any order during the course of treatment. Participants who could not tolerate a proteasome inhibitor or immunomodulatory drugs and an anti-CD38 monoclonal antibody are allowed
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
* Female participants of childbearing potential must use acceptable method of contraception
* Participants must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease
Exclusion Criteria:
* Prior treatment with any B cell maturation antigen (BCMA) targeted therapy
* Prior antitumor therapy as follows, before the first dose of study drug: Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less; Monoclonal antibody treatment for multiple myeloma within 21 days; Cytotoxic therapy within 21 days; Proteasome inhibitor therapy within 14 days; Immunomodulatory agent therapy within 7 days; Gene modified adoptive cell therapy (example, chimeric antigen receptor modified T cells, natural killer \[NK\] cells) within 3 months; Radiotherapy within 14 days or focal radiation within 7 days
* Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
* Received a cumulative dose of corticosteroids equivalent to \>= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
* Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
Primary outcome measure(s)
Dose Limiting Toxicity (DLT) — Up to Day 28 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.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability — Up to 7 years and 3 months An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Trial sites (13)
Facility
City
Region
Status
City of Hope
Duarte
California
Colorado Blood Cancer Institute
Denver
Colorado
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
New York
New York
Levine Cancer Institute
Charlotte
North Carolina
University of Pennsylvania
Philadelphia
Pennsylvania
Hospices Civils de Lyon HCL
Lyon
France
CHRU Tours Hopital Bretonneau
Tours
France
VU Medisch Centrum
Amsterdam
Netherlands
Hosp. Univ. Germans Trias I Pujol
Badalona
Spain
Hosp Clinic de Barcelona
Barcelona
Spain
Clinica Univ. de Navarra
Pamplona
Spain
Hosp Clinico Univ de Salamanca
Salamanca
Spain
Haematology Centre, R 51
Stockholm
Sweden
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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