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

NCT06425991 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 64007957MMY10082023-508426-10-00
• Study Type: interventional
• Target: 108
• Locations: 11 countries
• Sites: 53

Brief Summary

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).

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

1-3 prior lines

Outcome Measures

Primary Outcomes (3)

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

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

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

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

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

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

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

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

  Cycle 3 (28 days cycle): Day 1

Secondary Outcomes (7)

• Number of Participants with Anti-drug Antibodies (ADAs)

  Up to approximately 3 years

• Percentage of Participants With Complete Response (CR) or Better Response

  Up to approximately 3 years

• Number of Participants with Adverse Events (AEs) by Severity

  Up to approximately 3 years

• Number of Participants with Serious Adverse Events (SAEs)

  Up to approximately 3 years

• Number of Participants with Abnormal Laboratory Results

  Up to approximately 3 years

Study Arms (2)

Arm A: Pre-change Teclistamab

EXPERIMENTAL

Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.

Drug: Teclistamab

Arm B: Post-change Teclistamab

EXPERIMENTAL

Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first.

Drug: Teclistamab

Interventions

Teclistamab DRUG

Teclistamab will be administered subcutaneously.

Also known as: JNJ-64007957

Arm A: Pre-change Teclistamab; Arm B: Post-change Teclistamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (53)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Augusta University- Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health

Indianapolis, Indiana, 46237, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Flinders Medical Centre

Bedford Park, 5042, Australia

Location

Box Hill Hospital

Box Hill, 3128, Australia

Location

Royal Prince Alfred Hospital

Camperdown, 2050, Australia

Location

Epworth Healthcare

Richmond, 3121, Australia

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, M5G 1X6, Canada

Location

CHRU de Lille Hopital Claude Huriez

Lille, 59037, France

Location

Hospices Civils de Lyon HCL

Lyon, 69002, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU de Bordeaux - Hospital Haut-Leveque

Pessac, 33604, France

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09113, Germany

Location

Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20251, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Carmel Medical Center

Haifa, 3436212, Israel

Location

Hadassah University Hospita Ein Kerem

Jerusalem, 9112001, Israel

Location

Sheba Medical Center

Ramat Gan, 5266202, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Ospedali Riuniti Di Ancona

Ancona, 60126, Italy

Location

ASST Papa Giovanni XXIII Bergamo

Bergamo, 24127, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, 47014, Italy

Location

Ospedale Santa Chiara AO Universitaria Pisana

Pisa, 56126, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

Wojewodzki Szpital Specjalistyczny

Biała Podlaska, 21 500, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214, Poland

Location

Pratia Onkologia Katowice

Katowice, 40 519, Poland

Location

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, 25 734, Poland

Location

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, 20 090, Poland

Location

Dolnoslaskie Centrum Onkologii

Wroclaw, 53-439, Poland

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591, South Korea

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

ICO L'Hospitalet - Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: June 7, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 3, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (6); US (7); AU (4); IL (4); DE (4); KR (5); FR (4); CA (2); PL (6); ES (7); GB (4)