NCT03145181 · CITED IN SOURCE DOCUMENTS

Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE1
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-08-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants will receive Teclistamab intravenously (IV).
intervention Names
Drug: Teclistamab (IV)
label
Part 1: Dose Escalation (IV)
type
EXPERIMENTAL
description
Participants will receive Teclistamab IV.
intervention Names
Drug: Teclistamab (IV)
label
Part 2: Dose Expansion (IV)
type
EXPERIMENTAL
description
Participants will receive Teclistamab subcutaneously (SC).
intervention Names
Drug: Teclistamab(SC)
label
Part 1: Dose Escalation (SC)
type
EXPERIMENTAL
description
Participants will receive Teclistamab SC.
intervention Names
Drug: Teclistamab(SC)
label
Part 2: Dose Expansion (SC)
type
EXPERIMENTAL

interventions

arm Group Labels
Part 1: Dose Escalation (IV)
Part 2: Dose Expansion (IV)
description
Participants will receive IV infusion of Teclistamab.
name
Teclistamab (IV)
other Names
JNJ-64007957
type
DRUG
arm Group Labels
Part 1: Dose Escalation (SC)
Part 2: Dose Expansion (SC)
description
Participants will receive SC injection of Teclistamab.
name
Teclistamab(SC)
other Names
JNJ-64007957
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SEQUENTIAL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 302
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Dose Limiting Toxicity (DLT)
time Frame
Up to Day 28
description
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.
measure
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
time Frame
Up to 7 years and 3 months

secondary Outcomes

description
Concentration assessment will be done to evaluate the effect of Teclistamab.
measure
Teclistamab Serum Concentrations
time Frame
Up to 8 weeks
description
Antibodies to Teclistamab will be assessed to evaluate potential immunogenicity.
measure
Number of Participants with Teclistamab Antibodies
time Frame
Up to 8 weeks
description
Preliminary antitumor activity of Teclistamab will be done using the International Myeloma Working Group (IMWG) response criteria.
measure
Preliminary Antitumor Activity of Teclistamab at the RP2D(s) in Part 2
time Frame
Up to End of Treatment (Approximately 91 days)
description
Biomarker assessment may be done to evaluate the effect of Teclistamab.
measure
Biomarker Assessment
time Frame
Up to 8 weeks

Full study description

brief 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.
detailed Description: The study will be conducted in 2 parts, separately for IV and SC administration: dose escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of Teclistamab administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as 2 years after the last participant in Part 3 has received his or her initial dose of teclistamab. Study record NCT04557098 is Phase 2 part of this study and study record NCT03145181 is Phase 1 part of this study.

Source references

references

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