Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06425991

A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Flinders Medical Centre, Bedford Park, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria
  • Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2
  • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study

Exclusion criteria

  • Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy
  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
  • Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed
  • Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required
  • Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study

Treatment and study plan

Teclistamab

Drug

Teclistamab will be administered subcutaneously.

Other names: JNJ-64007957

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab

    Time frame: Cycle 1 (28 days cycle): Predose to Day 7 postdose

    Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose).

  2. Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose

    Time frame: Cycle 1 (28 days cycle): Predose to Day 7 postdose

    AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose).

  3. Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1

    Time frame: Cycle 3 (28 days cycle): Day 1

    Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration.

Secondary outcomes

  1. Number of Participants with Anti-drug Antibodies (ADAs)

    Time frame: Up to approximately 3 years

    Number of participants with ADAs to teclistamab will be reported.

  2. Percentage of Participants With Complete Response (CR) or Better Response

    Time frame: Up to approximately 3 years

    Percentage of participants with CR or better response will be reported. CR or better response rate is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.

  3. Number of Participants with Adverse Events (AEs) by Severity

    Time frame: Up to approximately 3 years

    An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.

  4. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to approximately 3 years

    SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important.

  5. Number of Participants with Abnormal Laboratory Results

    Time frame: Up to approximately 3 years

    Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported.

  6. Percentage of Participants With Overall Response (Partial Response [PR] or Better)

    Time frame: Up to approximately 3 years

    Percentage of participants with overall response (PR or better) will be reported. Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria.

  7. Percentage of Participants With Very Good Partial Response (VGPR) or Better Response

    Time frame: Up to approximately 3 years

    Percentage of participants with VGPR or better response will be reported. VGPR or better response rate is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma

Acronym: MajesTEC-10

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
May 23, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.