NCT04557098 · CITED IN SOURCE DOCUMENTS

A Study of Teclistamab 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: PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-07-31

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

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 IMWG diagnostic criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment * A female participant of childbearing potential must have a negative pregnancy test at screening * Willing and able to adhere to the prohibitions and restrictions specified in this protocol * Cohort A: received at least \>=3 prior lines of therapy and previously received a PI, an IMiD and an anti-CD38 monoclonal antibody; Cohort C: received \>= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC) Exclusion Criteria: * Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis * The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (\<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction \<= 6 m, stage III-IV congestive heart failure, etc) * Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3 * Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug * Toxicities from previous anticancer therapies that have not resolved to baseline or to \<= grade 1 (except for alopecia or peripheral neuropathy) * Received a cumulative dose of corticosteroids equivalent to \>=140 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 (MM) * Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence * Prior allogenic stem cell transplant \<=6 months * Prior autologous stem cell transplant \<=12 weeks * Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab
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 subcutaneously (SC) at recommended Phase 2 dose (RP2D) in Cohort A and Cohort C.
intervention Names
Drug: Teclistamab
label
Part 3: Teclistamab
type
EXPERIMENTAL

interventions

arm Group Labels
Part 3: Teclistamab
description
Teclistamab will be administered SC.
name
Teclistamab
other Names
JNJ-64007957
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 194
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Cohorts A and C: Overall Response Rate (ORR)
time Frame
Up to 2.9 years

secondary Outcomes

description
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.
measure
Cohorts A and C: Duration of Response (DOR)
time Frame
Up to 2.9 years
description
VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
measure
Cohorts A and C: Very Good Partial Response (VGPR) or Better Rate
time Frame
Up to 2.9 years
description
CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.
measure
Cohorts A and C: Cohorts A and C: Complete Response (CR) or Better Rate
time Frame
Up to 2.9 years
description
sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.
measure
Cohorts A and C: Stringent Complete Response (sCR) Rate
time Frame
Up to 2.9 years
description
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.
measure
Cohorts A and C: Time to Response (TTR)
time Frame
Up to 2.9 years
description
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.
measure
Cohorts A and C: Progression-free Survival (PFS)
time Frame
Up to 2.9 years
description
OS is defined as the time from the date of first dose of study drug to the date of the participant's death.
measure
Cohorts A and C: Overall Survival (OS)
time Frame
Up to 2.9 years
description
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
measure
Cohorts A and C: Minimal Residual Disease (MRD) Negative Rate
time Frame
Up to 2.9 years
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
Cohorts A and C: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
time Frame
Up to 2.9 years
description
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.
measure
Cohorts A and C: Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
time Frame
Up to 2.9 years
description
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.
measure
Cohorts A and C: Number of Participants with AEs by Severity
time Frame
Up to 2.9 years
description
Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.
measure
Cohorts A and C: Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values
time Frame
Up to 2.9 years

Full study description

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

Source references

references

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