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New antibody therapy shows promise for Hard-to-Treat multiple myeloma

NCT ID NCT03145181

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This early-stage study tests a new drug called teclistamab in people with multiple myeloma that has returned or stopped responding to other treatments. The main goal is to find a safe dose and check for side effects. About 300 participants will receive the drug to see how well it works and how the body handles it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

302 people

The number who actually took part.

Started

May 2017

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHRU Tours Hopital Bretonneau

    Tours, 37044, France

  • City of Hope

    Duarte, California, 91010, United States

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Haematology Centre, R 51

    Stockholm, SE-141 86, Sweden

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hospices Civils de Lyon HCL

    Lyon, 69002, France

  • Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects

    New York, New York, 10029, United States

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • VU Medisch Centrum

    Amsterdam, 1081 HV, Netherlands

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