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Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1)

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ClinicalTrials.gov Identifier: NCT03145181
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Drug: Teclistamab (IV) Drug: Teclistamab(SC) Phase 1

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, 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 : May 16, 2017
Actual Primary Completion Date : November 9, 2021
Estimated Study Completion Date : July 22, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Escalation (IV)
Participants will receive Teclistamab intravenously (IV).
 Drug: Teclistamab (IV)
Participants will receive IV infusion of Teclistamab.
Other Name: JNJ-64007957
Experimental: Part 2: Dose Expansion (IV)
Participants will receive Teclistamab IV.
 Drug: Teclistamab (IV)
Participants will receive IV infusion of Teclistamab.
Other Name: JNJ-64007957
Experimental: Part 1: Dose Escalation (SC)
Participants will receive Teclistamab subcutaneously (SC).
 Drug: Teclistamab(SC)
Participants will receive SC injection of Teclistamab.
Other Name: JNJ-64007957
Experimental: Part 2: Dose Expansion (SC)
Participants will receive Teclistamab SC.
 Drug: Teclistamab(SC)
Participants will receive SC injection of Teclistamab.
Other Name: JNJ-64007957


Outcome Measures
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Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: Up to Day 28 ]
    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.

  2. Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 7 years and 3 months ]
    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.


Secondary Outcome Measures :
  1. Teclistamab Serum Concentrations [ Time Frame: Up to 8 weeks ]
    Concentration assessment will be done to evaluate the effect of Teclistamab.

  2. Number of Participants with Teclistamab Antibodies [ Time Frame: Up to 8 weeks ]
    Antibodies to Teclistamab will be assessed to evaluate potential immunogenicity.

  3. Preliminary Antitumor Activity of Teclistamab at the RP2D(s) in Part 2 [ Time Frame: Up to End of Treatment (Approximately 91 days) ]
    Preliminary antitumor activity of Teclistamab will be done using the International Myeloma Working Group (IMWG) response criteria.

  4. Biomarker Assessment [ Time Frame: Up to 8 weeks ]
    Biomarker assessment may be done to evaluate the effect of Teclistamab.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145181


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
United States, New York
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects Recruiting
New York, New York, United States, 10029
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
France
Centre hospitalier Lyon-Sud Recruiting
Pierre Benite cedex, France, 69495
CHRU Tours Hopital Bretonneau Recruiting
Tours, France, 37044
Netherlands
VU Medisch Centrum Recruiting
Amsterdam, Netherlands, 1081 HV
Spain
Hosp. Univ. Germans Trias I Pujol Recruiting
Badalona, Spain, 08916
Hosp. Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Clinica Univ. de Navarra Recruiting
Pamplona, Spain, 31008
Hosp. Clinico Univ. de Salamanca Recruiting
Salamanca, Spain, 37007
Sweden
Haematology Centre, R 51 Recruiting
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03145181    
Other Study ID Numbers: CR108206
2016-002122-36 ( EudraCT Number )
64007957MMY1001 ( Other Identifier: Janssen Research & Development, LLC )
2023-503438-40-00 ( Registry Identifier: EUCT number )
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Hematologic Neoplasms
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site