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A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1)

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ClinicalTrials.gov Identifier: NCT04557098
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE September 17, 2020
First Posted Date  ICMJE September 21, 2020
Last Update Posted Date October 8, 2021
Actual Study Start Date  ICMJE September 17, 2020
Estimated Primary Completion Date April 23, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
Overall Response Rate (ORR) [ Time Frame: Up to 2.9 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2020)
  • Duration of Response (DOR) [ Time Frame: Up to 2.9 years ]
    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.
  • Very Good Partial Response (VGPR) or Better Rate [ Time Frame: Up to 2.9 years ]
    VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
  • Complete Response (CR) or Better Rate [ Time Frame: Up to 2.9 years ]
    CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.
  • Stringent Complete Response (sCR) Rate [ Time Frame: Up to 2.9 years ]
    sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.
  • Time to Response (TTR) [ Time Frame: Up to 2.9 years ]
    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.
  • Progression-free Survival (PFS) [ Time Frame: Up to 2.9 years ]
    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.
  • Overall Survival (OS) [ Time Frame: Up to 2.9 years ]
    OS is defined as the time from the date of first dose of study drug to the date of the participant's death.
  • Minimal Residual Disease (MRD) Negative Rate [ Time Frame: Up to 2.9 years ]
    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
  • Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 2.9 years ]
    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.
  • Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 2.9 years ]
    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.
  • Number of Participants with AEs by Severity [ Time Frame: Up to 2.9 years ]
    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 [ Time Frame: Up to 2.9 years ]
    Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.
  • Serum Concentration of Teclistamab [ Time Frame: Up to 3 months ]
    Serum concentrations of teclistamab will be reported.
  • Number of Participants with Teclistamab Antibodies [ Time Frame: Up to 2.9 years ]
    Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.
  • Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30) [ Time Frame: Baseline, up to 2.9 years ]
    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.
  • Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, up to 2.9 years ]
    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.
  • Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS) [ Time Frame: Baseline, up to 2.9 years ]
    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).
  • Overall Response Rate (ORR) in Participants with High-risk Molecular Features [ Time Frame: Up to 2.9 years ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
  • Duration of Response (DOR) [ Time Frame: Up to 2.9 years ]
    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.
  • Very Good Partial Response (VGPR) or Better Rate [ Time Frame: Up to 2.9 years ]
    VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
  • Complete Response (CR) or Better Rate [ Time Frame: Up to 2.9 years ]
    CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.
  • Stringent Complete Response (sCR) Rate [ Time Frame: Up to 2.9 years ]
    sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.
  • Time to Response (TTR) [ Time Frame: Up to 2.9 years ]
    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.
  • Progression-free Survival (PFS) [ Time Frame: Up to 2.9 years ]
    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.
  • Overall Survival (OS) [ Time Frame: Up to 2.9 years ]
    OS is defined as the time from the date of first dose of study drug to the date of the participant's death.
  • Minimal Residual Disease (MRD) Negative Rate [ Time Frame: Up to 2.9 years ]
    MRD-negative rate, as measured in participants who achieve CR/sCR, is defined as the proportion of participants who achieve MRD negative status.
  • Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 2.9 years ]
    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.
  • Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 2.9 years ]
    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.
  • Number of Participants with AEs by Severity [ Time Frame: Up to 2.9 years ]
    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 [ Time Frame: Up to 2.9 years ]
    Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported.
  • Serum Concentration of Teclistamab [ Time Frame: Up to 3 months ]
    Serum concentrations of teclistamab will be reported.
  • Number of Participants with Teclistamab Antibodies [ Time Frame: Up to 2.9 years ]
    Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.
  • Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30) [ Time Frame: Baseline, up to 2.9 years ]
    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.
  • Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, up to 2.9 years ]
    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.
  • Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS) [ Time Frame: Baseline, up to 2.9 years ]
    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).
  • Overall Response Rate (ORR) in Participants with High-risk Molecular Features [ Time Frame: Up to 2.9 years ]
    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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma
Official Title  ICMJE 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
Brief Summary The purpose of this study is evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).
Detailed Description Study record NCT03145181 is Phase 1 part of this study and study record NCT04557098 is Phase 2 part of this study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hematological Malignancies
Intervention  ICMJE Drug: Teclistamab
Teclistamab will be administered SC.
Other Name: JNJ-64007957
Study Arms  ICMJE Experimental: Part 3: Teclistamab
Participants in all cohorts will receive teclistamab SC at an RP2D.
Intervention: Drug: Teclistamab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2021)
192
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2020)
228
Estimated Study Completion Date  ICMJE September 7, 2024
Estimated Primary Completion Date April 23, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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: Multiple myeloma must be measurable by central laboratory assessment
  • Women 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 MM treatment lines of therapy. Prior therapy must include an IMiD, PI, and 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Belgium,   Canada,   China,   France,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04557098
Other Study ID Numbers  ICMJE CR108859
2016-002122-36 ( EudraCT Number )
TECLIMMY1001-P3 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP