New drug combo aims to control Hard-to-Treat myeloma
NCT ID NCT05338775
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This early-stage study tests whether combining two types of immune-boosting drugs (bispecific antibodies and a checkpoint inhibitor) is safe for people with multiple myeloma that has come back or stopped responding to treatment. About 74 participants will receive either talquetamab or teclistamab together with a PD-1 inhibitor. The main goal is to find safe doses and check for side effects, not to cure the disease.
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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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74 people
The number who actually took part.
- Started
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May 2022
- Expected to finish
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May 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.
Show the full entry requirements Hide 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: * Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit * Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level \>= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligrams/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: * Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor \[PI\] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months) * Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant * Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis * Active Central Nervous System (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required * Live, attenuated vaccine within 4 weeks before the first dose of study treatment * Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia \[any grade\] or peripheral neuropathy to Grade \<= 2) * Received a cumulative dose of corticosteroids equivalent to \>= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration
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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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CHU Poitiers - Hopital la Miletrie
Poitiers, 86021, France
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CHU de Montpellier Hopital Saint Eloi
Montpellier, 34295, France
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CHU de Nantes hotel Dieu
Nantes, 44093, France
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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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Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
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Hosp Univ Fund Jimenez Diaz
Madrid, 28040, Spain
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Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059, France
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
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The Blavatnik Family Chelsea Medical Center at Mount Sinai
New York, New York, 10011, United States
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Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
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Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
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Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
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Universitatsklinikum Wurzburg
Würzburg, 97080, Germany
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Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a tropical tea shrink blood cancers?
- Engineered immune cells take aim at Hard-to-Treat myeloma
- Can engineered immune cells outsmart Treatment-Resistant myeloma?
- Can a lower dose of a myeloma drug keep the disease in check with fewer side effects?
- A pre-treatment pill may supercharge cancer-fighting immune cells