The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Hematological Malignancies

Hematologic Neoplasms

Hematologic Malignancies

Blood Cancer

Teclistamab

TECLIMMY1001-P3: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

ORR is defined as the proportion of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.

DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to PD, whichever occurs first.

VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.

CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.

sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.

TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.

PFS is defined as the time from the date of first dose of study drug to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.

OS is defined as the time from the date of first dose of study drug to the date of the participant's death.

MRD-negative rate is defined as the proportion of participants who achieved MRD-negative status to a threshold of 10^-5 at any timepoint after initial dose of teclistamab and before disease progression or starting subsequent therapy

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.

An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.

Serum concentrations of teclistamab will be reported.

Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.

The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week"), and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.

The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).

ORR in participants with high risk is defined as the overall response rate among the high-risk molecular subgroups (del17p, t(4;14), t(14;16), or other high-risk molecular subtypes).

Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) in Cohort A and Cohort C.

The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase
      2 dose (RP2D).

Study record NCT03145181 is Phase 1 part of this study and study record NCT04557098 is Phase
      2 part of this study.

University of Alabama at Birmingham

City of Hope

University of California, San Francisco

Stanford University Medical Center

Winship Cancer Institute Emory University

Barbara Ann Karmanos Cancer Institute

Icahn School of Medicine at Mount Sinai

Memorial Sloan-Kettering Cancer Center

Levine Cancer Institute

University of Pennsylvania

Universitair Ziekenhuis Gent - UZ GENT

Universitaire Ziekenhuizen Leuven

Tom Baker Cancer Centre

Cross Cancer Institute

University Health Network (UHN) Princess Margaret Cancer Centre

McGill University Health Centre

Peking University First Hospital

West China Hospital, Si Chuan University

Sun Yat -Sen University Cancer Center

First affiliated Hospital of Zhejiang University

Shanghai Changzheng Hospital

Shengjing Hospital of China Medical University

Tianjin Medical University Cancer Institute and Hospital

The Second Affiliated Hospital of Xi'an Jiaotong University

Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

C.H.U. Hotel Dieu - France

Centre Hospitalier Lyon Sud

CHRU Hôpital Jean Bernard

Pôle IUC Oncopole CHU

CHRU Hôpital Bretonneau

Universitaetsklinikum Heidelberg

Universitaetsklinikum Leipzig

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

Universitätsklinikum Würzburg

Azienda Ospedaliera Papa Giovanni XXIII

Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

Fondazione IRCCS Istituto Nazionale dei Tumori

VU Medisch Centrum

Hosp. Univ. Germans Trias I Pujol

Hosp. Clinic I Provincial de Barcelona

Hosp. Univ. 12 de Octubre

Clinica Univ. de Navarra

Hosp. Quiron Madrid Pozuelo

Hosp. Clinico Univ. de Salamanca

Hosp. Univ. Marques de Valdecilla

Sahlgrenska University Hospital

Skane University Hospital

Haematology Centre, R 51

University College Hospital

University Hospital Southampton

Royal Marsden Hospital

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) (Cohort A and Cohort C) and will receive alternative dosing schedule of teclistamab (Cohort D).

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Trials at a glance

Trials at a glance

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Outcome measures

Primary outcome measures

Secondary outcome measures