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Multiple MyelomaPhase 1MajesTEC-10NCT06425991

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

A Phase 1 study testing Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 53 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Teclistamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
53 sitesin 11 countries
Study dates
7 Jun 2024to 13 Jan 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

53 sites in 11 countries.

53 sites in 11 countries

United States7 sites

  • Augusta University- Georgia Cancer Center

    Augusta, Georgia, 30912

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

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

    Indianapolis, Indiana, 46237

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

Spain7 sites

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • ICO L'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

Other trials in Spain

Italy6 sites

  • Ospedali Riuniti Di Ancona

    Ancona, 60126

  • ASST Papa Giovanni XXIII Bergamo

    Bergamo, 24127

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Ospedale Santa Chiara AO Universitaria Pisana

    Pisa, 56126

  • Policlinico Universitario Agostino Gemelli

    Rome, 00168

Other trials in Italy

Poland6 sites

  • Wojewodzki Szpital Specjalistyczny

    Biała Podlaska, 21 500

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

  • Pratia Onkologia Katowice

    Katowice, 40 519

  • Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

    Kielce, 25 734

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20 090

  • Dolnoslaskie Centrum Onkologii

    Wroclaw, 53-439

Other trials in Poland

South Korea5 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

Other trials in South Korea

Australia4 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Box Hill Hospital

    Box Hill, 3128

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • Epworth Healthcare

    Richmond, 3121

Other trials in Australia

France4 sites

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037

  • Hospices Civils de Lyon HCL

    Lyon, 69002

  • CHU Nantes

    Nantes, 44093

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604

Other trials in France

Germany4 sites

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20251

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Israel4 sites

  • Carmel Medical Center

    Haifa, 3436212

  • Hadassah University Hospita Ein Kerem

    Jerusalem, 9112001

  • Sheba Medical Center

    Ramat Gan, 5266202

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

United Kingdom4 sites

  • Hammersmith Hospital

    London, W12 0HS

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX

  • Norfolk & Norwich University Hospital

    Norwich, NR4 7UY

  • Derriford Hospital

    Plymouth, PL6 8DH

Other trials in United Kingdom

Canada2 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1X6

Other trials in Canada

About this study

Official title: A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/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).

Being tested
Teclistamab
Keywords
1-3 prior lines
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeclistamabDrug

    Also called JNJ-64007957

    Teclistamab will be administered subcutaneously.

Study groups in NCT06425991
Study groupRoleWhat they receive
Arm A: Pre-change TeclistamabExperimentalParticipants 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. Following completion of the planned analysis per protocol, approval of Amendment 3, and upon sponsor notification, participants from treatment phase will be transitioned to Drug Access Long-term Extension (DA-LTE) phase and will continue to receive the study treatment until they have either discontinued, withdrawn, or transitioned to one of the criteria specified in the protocol. Based on primary analysis demonstrating comparability between pre- and post-change teclistamab, flexibility has been introduced to allow participants to switch from their current teclistamab treatment, if necessary.
Receives: Drug: Teclistamab
Arm B: Post-change TeclistamabExperimentalParticipants 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. Following completion of the planned analysis per protocol, approval of Amendment 3, and upon sponsor notification, participants from treatment phase will be transitioned to DA-LTE phase to receive the study treatment until they have either discontinued, withdrawn, or transitioned to one of the criteria specified in the protocol. Based on primary analysis demonstrating comparability between pre- and post-change teclistamab, flexibility has been introduced to allow participants to switch from their current teclistamab treatment, if necessary.
Receives: Drug: Teclistamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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).

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

  3. 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.

    Measured: Cycle 3 (28 days cycle): Day 1

Secondary outcomes (7)

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

    Number of participants with ADAs to teclistamab will be reported.

    Measured: Up to approximately 3 years

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

    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.

    Measured: Up to approximately 3 years

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

    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.

    Measured: Up to approximately 3 years

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

    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.

    Measured: Up to approximately 3 years

  5. Number of Participants with Abnormal Laboratory Results

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

    Measured: Up to approximately 3 years

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

    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.

    Measured: Up to approximately 3 years

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

    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.

    Measured: Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2024
  2. Study start7 Jun 2024
  3. Primary completion21 Apr 2025
  4. Study completion13 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06425991
Sponsor's protocol ID
64007957MMY1008
Other IDs
2023-508426-10-00, 2023
Acronym
MajesTEC-10
Status last verified
Nov 2026
First submitted
17 May 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 53 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Spain, Italy, Poland, South Korea and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab (time frame: Cycle 1 (28 days cycle): Predose to Day 7 postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06425991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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