New antibody combo shows promise for Hard-to-Treat myeloma
NCT ID NCT04910568
First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 10 times
Summary
This early-phase trial is testing an experimental antibody called cevostamab, either alone or combined with other drugs (pomalidomide, daratumumab, and dexamethasone), in 126 people with multiple myeloma that has returned or stopped responding to treatment. The main goals are to find the safest dose and check for side effects. Researchers will also look at how well the cancer responds and how long any benefit lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cevostamab (an experimental antibody), pomalidomide, daratumumab, dexamethasone, tocilizumab
- What this could lead to
- If successful, this could point toward a new treatment option for people with multiple myeloma that has stopped responding to other therapies.
- What could go wrong
- This is an early-phase trial with only 126 participants, so results may not apply to everyone. Side effects like cytokine release syndrome are possible, and the drug may not work as hoped.
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
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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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About 186 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Dec 2028
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: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Agreement to provide bone marrow biopsy and aspirate samples * Resolution of adverse events from prior anti-cancer therapy to Grade \<=1 * Measurable disease * For women of childbearing potential: agreement to remain abstinent or use contraception, during the treatment period (including treatment interruptions) and for at least 5 months after the last dose of cevostamab and at least 3 months after the last dose of tocilizumab was administered * For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, during the treatment period, and for at least 2 months after the last dose of tocilizumab was administered to avoid exposing the embryo and sexual partner Additional Arm A-Specific Inclusion Criteria * Diagnosis of R/R MM for which no established therapy for MM is appropriate and available, or intolerance to those established therapies Additional Arm B-Specific Inclusion Criteria * For Cohort B1S: Participants with R/R MM who have received at least two prior lines of treatment, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) * For Cohort B2S, B1E, B3E: Participants with R/R MM who have received at least one prior line of treatment that included at least two consecutive cycles of treatment, including a PI and an IMiD * For Cohort B4E: Participants with R/R MM who have received one to four lines of prior therapy that included at least two consecutive cycles of anti-CD38 therapy, lenalidomide and a PI, and either: Prior B-cell maturation antigen- (BCMA)-targeted therapy-directed chimeric antigen receptor T (CAR T) cell therapy or Prior BCMA-antibody-drug conjugate (ADC) therapy * Agreement to comply with all requirements of the pomalidomide pregnancy prevention program * For women of childbearing potential: agreement to remain abstinent or use two reliable methods of contraception starting at least 4 weeks prior to, during the treatment period, and for at least 4 weeks after the last dose of pomalidomide was administered * For men: agreement to remain abstinent or use a condom during the treatment period and for at least 4 weeks after the last dose of pomalidomide, (even if he has undergone a successful vasectomy) and agreement to refrain from donating sperm and blood during this same period Additional Arm C-Specific Inclusion Criteria * For Cohort C1S: Patients with R/R MM who have received at least two prior lines of treatment including a PI and an IMiD * For Cohort C2S and additional cohorts: Participants with R/R MM who have received at least 1 prior line of therapy * For women of childbearing potential: agreement to remain abstinent or use contraceptive methods during the treatment period and for at least 102 days after the last dose of daratumumab was administered * For men: agreement to remain abstinent or use a condom during the treatment period and for at least 102 days after the last dose of daratumumab was administered to avoid exposing the embryo, and agreement to refrain from donating sperm during this same period Exclusion Criteria: * Prior treatment with cevostamab or another agent targeting FcRH5 * Inability to comply with protocol-mandated hospitalization and activities restrictions * Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the last dose of cevostamab or within 3 months after the last dose of tocilizumab (if applicable). * Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drugconjugate as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy * Prior treatment with systemic immunotherapeutic agents, including, but not limited to, cytokine therapy and anti-CTLA4, anti-PD-1, and antiPD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first study treatment * Prior treatment with CAR T-cell therapy within 12 weeks before first study treatment * Treatment with radiotherapy within 4 weeks (systemic radiation) or 14 days (focal radiation) prior to first study treatment * Treatment with any chemotherapeutic agent or other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment * Autologous SCT within 100 days prior to first study treatment * Prior allogeneic stem cell transplant(ation) (SCT) * Circulating plasma cell count exceeding 500/micro L or 5% of the peripheral blood white cells * Prior solid organ transplantation * History of autoimmune disease * History of confirmed progressive multifocal leukoencephalopathy * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy * Known history of amyloidosis * Lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare * History of other malignancy within 2 years prior to screening * Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors * Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM * Significant cardiovascular disease * Symptomatic active pulmonary disease or requiring supplemental oxygen * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection * Known or suspected chronic active Epstein-Barr virus (EBV) infection * Recent major surgery within 4 weeks prior to first study treatment * Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection * Acute or chronic hepatitis C virus (HCV) infection * Known history of Grade \>= 3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies * Known history of hemophagocytic lymphohistiocytosis (HLH) or immune effector cell associated hemophagocytic lymphohistiocytosis like syndrome (IEC HS) * Active symptomatic coronavirus disease 2019 (COVID-19) infection at study enrollment or requiring treatment with intravenous (IV) antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Patients with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment * Positive and quantifiable EBV polymerase chain reaction (PCR) or Cytomegalovirus (CMV) PCR prior to first study treatment * Known history of HIV seropositivity * Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a live attenuated vaccine will be required during the study * Treatment with systemic immunosuppressive medications, with the exception of corticosteroid treatment \<=10 mg/day prednisone or equivalent, within 2 weeks prior to first study treatment * History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment Additional Arm B-Specific Exclusion Criteria * Pregnant or breastfeeding, or intending to become pregnant 4 weeks prior to initiation of study treatment, during the study, (including treatment interruptions) or within 4 weeks after the last dose of pomalidomide * Significant cardiovascular disease (such as, but not limited to, New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 12 months, uncontrolled arrhythmias, or unstable angina) * History of erythema multiforme, Grade \>=3 rash, blistering, or severe hypersensitivity to prior treatment with immunomodulatory drugs such as thalidomide, lenalidomide, or pomalidomide * Inability to tolerate thromboprophylaxis, or contraindication to thromboprophylaxis * GI disease that might significantly alter absorption of oral drugs Additional Arm C-Specific Exclusion Criteria * Pregnant or breastfeeding, or intending to become pregnant during the study or within 102 days after the last dose of daratumumab * Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of daratumumab formulations * Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal * Known moderate or severe persistent asthma within the past 2 years, or current uncontrolled asthma of any classification
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
COMPLETEDBrescia, Lombardy, 25123, Italy
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Asst Papa Giovanni Xxiii
ACTIVE_NOT_RECRUITINGBergamo, Lombardy, 24127, Italy
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CHU Pontchaillou
WITHDRAWNRennes, 35003, France
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CHU de Poitiers - La Miletrie
ACTIVE_NOT_RECRUITINGPoitiers, 86021, France
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City of Hope
ACTIVE_NOT_RECRUITINGDuarte, California, 91010, United States
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City of Hope - Lennar Foundation Cancer Center
ACTIVE_NOT_RECRUITINGIrvine, California, 92618, United States
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Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
RECRUITINGDenver, Colorado, 80218, United States
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Cross Cancer Institute
ACTIVE_NOT_RECRUITINGEdmonton, Alberta, T6G 1Z2, Canada
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Fakultni Nemocnice Ostrava
ACTIVE_NOT_RECRUITINGOstrava, 708 52, Czechia
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Hamilton Health Sciences
ACTIVE_NOT_RECRUITINGHamilton, Ontario, L8V 5C2, Canada
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Hospital General Universitario Gregorio Marañon
ACTIVE_NOT_RECRUITINGMadrid, 28009, Spain
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Hospital Universitari Vall d'Hebron
ACTIVE_NOT_RECRUITINGBarcelona, 08035, Spain
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Hôpital Saint-Louis
WITHDRAWNParis, 75475, France
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I Interni klinika
WITHDRAWNPrague, 128 08, Czechia
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Karmanos Cancer Institute.
COMPLETEDDetroit, Michigan, 48201, United States
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Nagoya City University Hospital
WITHDRAWNAichi, 467-8602, Japan
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National Hospital Organization Okayama Medical Center
WITHDRAWNOkayama, 701-1192, Japan
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Peter MacCallum Cancer Centre
ACTIVE_NOT_RECRUITINGMelbourne, Victoria, 3002, Australia
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Pratia Onkologia Katowice
ACTIVE_NOT_RECRUITINGKatowice, 41-500, Poland
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Rambam Medical Center
ACTIVE_NOT_RECRUITINGHaifa, 3109601, Israel
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Rigshospitalet
ACTIVE_NOT_RECRUITINGKøbenhavn Ø, 2100, Denmark
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Royal Marsden Hospital
ACTIVE_NOT_RECRUITINGSutton, SW3 6JJ, United Kingdom
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Samsung Medical Center
ACTIVE_NOT_RECRUITINGSeoul, 06351, South Korea
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Seoul National University Hospital
ACTIVE_NOT_RECRUITINGSeoul, 03080, South Korea
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Sourasky Medical Centre
RECRUITINGTel Aviv, 6423906, Israel
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The Alfred Hospital
RECRUITINGMelbourne, Victoria, 3004, Australia
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The Cancer Institute Hospital of JFCR
WITHDRAWNTokyo, 135-8550, Japan
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University College London Hospitals NHS Foundation Trust
RECRUITINGLondon, W1T 7HA, United Kingdom
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University Health Network
ACTIVE_NOT_RECRUITINGToronto, Ontario, M5G 2M9, Canada
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Uniwersytecki Szpital Kliniczny w Poznaniu
WITHDRAWNPóźna, 60-569, Poland
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Uniwersyteckie Centrum Kliniczne
WITHDRAWNGdansk, 80-214, Poland
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Washington University School of Medicine
ACTIVE_NOT_RECRUITINGSt Louis, Missouri, 63110, United States
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Winship Cancer Institute
WITHDRAWNAtlanta, Georgia, 30322, United States
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Yamagata University Hospital
ACTIVE_NOT_RECRUITINGYamagata, 990-9585, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?