New antibody therapy shows promise for Hard-to-Treat multiple myeloma
NCT ID NCT03145181
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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302 people
The number who actually took part.
- Started
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May 2017
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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CHRU Tours Hopital Bretonneau
Tours, 37044, France
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City of Hope
Duarte, California, 91010, United States
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Clinica Univ. de Navarra
Pamplona, 31008, Spain
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Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
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Haematology Centre, R 51
Stockholm, SE-141 86, Sweden
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Hosp Clinic de Barcelona
Barcelona, 08036, Spain
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Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
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Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
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Hospices Civils de Lyon HCL
Lyon, 69002, France
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Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
New York, New York, 10029, United States
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Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
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