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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04557098
Collaborator
(none)
192
Enrollment
81
Locations
1
Arm
51.4
Anticipated Duration (Months)
2.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
192 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 17, 2020
Actual Primary Completion Date :
Nov 9, 2021
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 3: Teclistamab

Participants in all cohorts will receive teclistamab SC at an RP2D.

Drug: Teclistamab
Teclistamab will be administered SC.
Other Names:
  • JNJ-64007957

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) [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.

    Secondary Outcome Measures

    1. Duration of Response (DOR) [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.

    2. Very Good Partial Response (VGPR) or Better Rate [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.

    3. Complete Response (CR) or Better Rate [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.

    4. Stringent Complete Response (sCR) Rate [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.

    5. Time to Response (TTR) [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.

    6. Progression-free Survival (PFS) [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.

    7. Overall Survival (OS) [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.

    8. Minimal Residual Disease (MRD) Negative Rate [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

    9. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [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.

    10. Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability [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.

    11. Number of Participants with AEs by Severity [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.

    12. Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values [Up to 2.9 years]

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

    13. Serum Concentration of Teclistamab [Up to 3 months]

      Serum concentrations of teclistamab will be reported.

    14. Number of Participants with Teclistamab Antibodies [Up to 2.9 years]

      Antibodies to teclistamab will be assessed to evaluate potential immunogenicity.

    15. 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) [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.

    16. Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) [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.

    17. Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS) [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).

    18. Overall Response Rate (ORR) in Participants with High-risk Molecular Features [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Mayo Clinic Cancer Center-Scottsdale Phoenix Arizona United States 85054
    3 City of Hope Duarte California United States 91010
    4 University of California, San Francisco San Francisco California United States 94143
    5 Stanford University Medical Center Stanford California United States 94305-5623
    6 Yale University New Haven Connecticut United States 06510
    7 Mayo Clinic in Florida Jacksonville Florida United States 32224
    8 Winship Cancer Institute Emory University Atlanta Georgia United States 30322
    9 University of Kansas Westwood Kansas United States 66205
    10 Dana-Farber Cancer Institute Boston Massachusetts United States 02215-5418
    11 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    12 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    13 Hackensack University Medical Center Hackensack New Jersey United States 07601
    14 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    15 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
    16 Mayo Clinic Cancer Center Rochester New York United States 55905
    17 Levine Cancer Institute Charlotte North Carolina United States 28204
    18 Duke University Medical Center Durham North Carolina United States 27710
    19 The Ohio State University Wexner Medical Center - James Cancer Hospital Columbus Ohio United States 43210
    20 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    21 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    22 Vanderbilt - Ingram Cancer Center Nashville Tennessee United States 37212
    23 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    24 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    25 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    26 Medical College Of Wisconsin Milwaukee Wisconsin United States 53226
    27 Universitair Ziekenhuis Gent - UZ GENT Gent Belgium 9000
    28 Universitaire Ziekenhuizen Leuven Leuven Belgium 3000
    29 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
    30 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    31 University Health Network (UHN) Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9
    32 McGill University Health Centre Montreal Quebec Canada H4A 3J1
    33 Peking University First Hospital Beijing China 100034
    34 The second Xiangya Hospital of Central South University ChangSha China 410000
    35 West China Hospital, Si Chuan University Chengdu China 610041
    36 Fujian Medical University Union Hospital Fuzhou China 350001
    37 Sun Yat -Sen University Cancer Center Guangzhou China 510060
    38 First affiliated Hospital of Zhejiang University Hangzhou China 310003
    39 Shanghai Changzheng Hospital Shanghai China 200003
    40 Shengjing Hospital of China Medical University Shenyang China 110004
    41 Peking University Shenzhen Hospital Shenzhen China 518035
    42 Tianjin Medical University Cancer Institute and Hospital Tianjin China 30060
    43 The First Affiliated Hospital of Wenzhou Medical University Wenzhou China 325000
    44 The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an China 710004
    45 Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez Lille Cedex France 59000
    46 C.H.U. Hotel Dieu - France Nantes France 44093
    47 Centre Hospitalier Lyon Sud Pierre Benite France 69495
    48 CHRU Hôpital Jean Bernard Poitiers France 86021
    49 Pôle IUC Oncopole CHU Toulouse cedex 9 France 31059
    50 CHRU Hôpital Bretonneau Tours France 37044
    51 Universitätsklinikum Carl-Gustav-Carus Dresden Dresden Germany 01307
    52 Universitaetsklinikum Hamburg Eppendorf Hamburg Germany 20246
    53 Universitaetsklinikum Heidelberg Heidelberg Germany 69120
    54 Universitaetsklinikum Koeln Koeln Germany 50937
    55 Universitatsklinikum Leipzig Leipzig Germany 04103
    56 Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, Tübingen Germany 72076
    57 Universitätsklinikum Würzburg Würzburg Germany 97080
    58 Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy 24127
    59 Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi Bologna Italy 40138
    60 Fondazione IRCCS Istituto Nazionale dei Tumori Milano Italy 20133
    61 A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette Turin Italy 10126
    62 VU Medisch Centrum Amsterdam Netherlands 1081 HV
    63 Universitair Medisch Centrum Groningen Groningen Netherlands 9713 GZ
    64 Erasmus MC Rotterdam Netherlands 3075 EA
    65 Hosp. Univ. Germans Trias I Pujol Badalona Spain 08916
    66 Hosp. Clinic I Provincial de Barcelona Barcelona Spain 08036
    67 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    68 Clinica Univ. de Navarra Pamplona Spain 31008
    69 Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcon Spain 28223
    70 Hosp. Clinico Univ. de Salamanca Salamanca Spain 37007
    71 Hosp. Univ. Marques de Valdecilla Santander Spain 39008
    72 Sahlgrenska University Hospital Göteborg Sweden 413 45
    73 Skane University Hospital Lund Sweden 221 85
    74 Haematology Centre, R 51 Stockholm Sweden SE-141 86
    75 University College Hospital London United Kingdom NW1 2PG
    76 King's College Hospital London United Kingdom SE5 9RS
    77 The Christie Nhs Foundation Trust Manchester United Kingdom M20 4BX
    78 Newcastle Freeman Hospital Newcastle Upon Tyne United Kingdom NE7 7DN
    79 Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom OX3 7LE
    80 University Hospital Southampton Sothampton United Kingdom SO16 6YD
    81 Royal Marsden Hospital Sutton United Kingdom SM2 5PT

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04557098
    Other Study ID Numbers:
    • CR108859
    • 2016-002122-36
    • TECLIMMY1001-P3
    First Posted:
    Sep 21, 2020
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Aug 12, 2022