A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

Last updated: March 17, 2026
Sponsor: Genentech, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Lymphoproliferative Disorders

Multiple Myeloma

Cancer/tumors

Treatment

Tocilizumab

Dexamethasone

Pomalidomide

Clinical Study ID

NCT04910568
GO42552
2021-000238-33
  • Ages > 18
  • All Genders

Study Summary

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

Eligibility Criteria

Inclusion

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 usecontraception, during the treatment period (including treatment interruptions) andfor at least 5 months after the last dose of cevostamab and at least 3 months afterthe last dose of tocilizumab was administered

  • For men: agreement to remain abstinent or use a condom, and agreement to refrainfrom donating sperm, during the treatment period, and for at least 2 months afterthe last dose of tocilizumab was administered to avoid exposing the embryo andsexual partner Additional Arm A-Specific Inclusion Criteria

  • Diagnosis of R/R MM for which no established therapy for MM is appropriate andavailable, or intolerance to those established therapies Additional Arm B-SpecificInclusion Criteria

  • For Cohort B1S: Participants with R/R MM who have received at least two prior linesof treatment

  • For Cohort B2S and additional cohorts: Participants with R/R MM who have received atleast 1 prior line of treatment

  • Agreement to comply with all requirements of the pomalidomide pregnancy preventionprogram

  • For women of childbearing potential: agreement to remain abstinent or use tworeliable methods of contraception starting at least 4 weeks prior to, during thetreatment period, and for at least 4 weeks after the last dose of pomalidomide wasadministered

  • For men: agreement to remain abstinent or use a condom during the treatment periodand for at least 4 weeks after the last dose of pomalidomide, (even if he hasundergone a successful vasectomy) and agreement to refrain from donating sperm andblood during this same period Additional Arm C-Specific Inclusion Criteria

  • For Cohort C1S: Participants with R/R MM who have received at least two prior linesof treatment

  • For Cohort C2S and additional cohorts: Participants with R/R MM who have received atleast 1 prior line of therapy

  • For women of childbearing potential: agreement to remain abstinent or usecontraceptive methods during the treatment period and for at least 102 days afterthe last dose of daratumumab was administered

  • For men: agreement to remain abstinent or use a condom during the treatment periodand for at least 102 days after the last dose of daratumumab was administered toavoid exposing the embryo, and agreement to refrain from donating sperm during thissame period

Exclusion

Exclusion Criteria:

  • Prior treatment with cevostamab or another agent targeting FcRH5

  • Inability to comply with protocol-mandated hospitalization and activitiesrestrictions

  • Pregnant or breastfeeding, or intending to become pregnant during the study orwithin 5 months after the last dose of cevostamab or within 3 months after the lastdose of tocilizumab (if applicable).

  • Prior use of any monoclonal antibody, radioimmunoconjugate, orantibody-drugconjugate as anti-cancer therapy within 4 weeks before first studytreatment, except for the use of non-myeloma therapy

  • Prior treatment with systemic immunotherapeutic agents, including, but not limitedto, cytokine therapy and anti-CTLA4, anti-PD-1, and antiPD-L1 therapeutic antibodieswithin 12 weeks or 5 half-lives of the drug, whichever is shorter, before firststudy treatment

  • Prior treatment with chimeric antigen receptor T (CAR T)-cell therapy within 12weeks before first study treatment

  • Treatment with radiotherapy within 4 weeks (systemic radiation) or 14 days (focalradiation) 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, whicheveris 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 bloodwhite 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 suddendecompensation/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 priorcheckpoint 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 neurotoxicitysyndrome (ICANS) with prior bispecific therapies

  • Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activationsyndrome (MAS)

  • Active symptomatic coronavirus disease 2019 (COVID-19) infection at study enrollmentor requiring treatment with intravenous (IV) antiviral where the last dose of IVantiviral treatment was given within 14 days prior to first study treatment.Patients with active COVID-19 infection must have clinical recovery and two negativeantigen 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 studytreatment or anticipation that such a live attenuated vaccine will be requiredduring the study

  • Treatment with systemic immunosuppressive medications, with the exception ofcorticosteroid treatment <=10 mg/day prednisone or equivalent, within 2 weeks priorto first study treatment

  • History of illicit drug or alcohol abuse within 12 months prior to screening, in theinvestigator's judgment Additional Arm B-Specific Exclusion Criteria

  • Pregnant or breastfeeding, or intending to become pregnant 4 weeks prior toinitiation 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 HeartAssociation 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 severehypersensitivity 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 ArmC-Specific Exclusion Criteria

  • Pregnant or breastfeeding, or intending to become pregnant during the study orwithin 102 days after the last dose of daratumumab

  • Known hypersensitivity to biopharmaceuticals produced in CHO cells or any componentof daratumumab formulations

  • Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volumein 1 second (FEV1) <50% of predicted normal

  • Known moderate or severe persistent asthma within the past 2 years, or currentuncontrolled asthma of any classification

Study Design

Total Participants: 126
Treatment Group(s): 5
Primary Treatment: Tocilizumab
Phase: 1
Study Start date:
July 26, 2021
Estimated Completion Date:
December 10, 2029

Connect with a study center

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre; Department of Haematology

    Melbourne, Victoria 3002
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • The Alfred Hospital; Malignant Haematology & Stem Cell Transplant Service

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne 2158177, Victoria 2145234 3002
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234 3004
    Australia

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton 5946768, Alberta 5883102 T6G 1Z2
    Canada

    Site Not Available

  • Hamilton Health Sciences

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • University Health Network

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Hamilton Health Sciences

    Hamilton 5969782, Ontario 6093943 L8V 5C2
    Canada

    Site Not Available

  • University Health Network

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52
    Czechia

    Site Not Available

  • Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU

    Ostrava, 708 52
    Czechia

    Site Not Available

  • Fakultni Nemocnice Ostrava

    Ostrava 3068799, 708 52
    Czechia

    Site Not Available

  • I Interni klinika

    Prague 2, 128 08
    Czechia

    Site Not Available

  • I Interni klinika; Vseobecna fakultni nemocnice

    Prague 2, 128 08
    Czechia

    Site Not Available

  • Rigshospitalet

    København Ø, 2100
    Denmark

    Site Not Available

  • Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

    København Ø, 2100
    Denmark

    Site Not Available

  • Rigshospitalet

    København Ø 11746747, 2100
    Denmark

    Site Not Available

  • Hôpital Saint-Louis

    Paris, 75475
    France

    Site Not Available

  • Hôpital Saint-Louis; Service d'Hématologie

    Paris, 75475
    France

    Site Not Available

  • Hôpital Saint-Louis

    Paris 2988507, 75475
    France

    Site Not Available

  • CHU de Poitiers - La Miletrie

    Poitiers, 86021
    France

    Site Not Available

  • CHU de Poitiers - La Miletrie; Oncologie hematologique - Pole Regional de Cancerologie

    Poitiers, 86021
    France

    Site Not Available

  • CHU de Poitiers - La Miletrie

    Poitiers 2986495, 86021
    France

    Site Not Available

  • CHU Pontchaillou

    Rennes, 35003
    France

    Site Not Available

  • CHU Pontchaillou; Service Hématologie

    Rennes, 35003
    France

    Site Not Available

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Site Not Available

  • Rambam Medical Center; Heamatology & Bone Marrow Transplantation

    Haifa, 3109601
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Sourasky Medical Centre

    Tel-Aviv, 6423906
    Israel

    Site Not Available

  • ASST PAPA GIOVANNI XXIII; Ematologia

    Bergamo, Lombardia 24127
    Italy

    Site Not Available

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

    Brescia, Lombardia 25123
    Italy

    Site Not Available

  • Asst Papa Giovanni Xxiii

    Bergamo, Lombardy 24127
    Italy

    Site Not Available

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

    Brescia, Lombardy 25123
    Italy

    Site Not Available

  • Asst Papa Giovanni Xxiii

    Bergamo 3182164, Lombardy 3174618 24127
    Italy

    Site Not Available

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

    Brescia 3181554, Lombardy 3174618 25123
    Italy

    Site Not Available

  • Nagoya City University Hospital

    Aichi, 467-8602
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550
    Japan

    Site Not Available

  • Yamagata University Hospital

    Yamagata, 990-9585
    Japan

    Site Not Available

  • Yamagata University Hospital

    Yamagata 2110556, 990-9585
    Japan

    Site Not Available

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne; Kilnika Hematologii i Transplantologii, Oddzia? Wczesnych Faz

    Gda?sk, 80-214
    Poland

    Site Not Available

  • Pratia Onkologia Katowice

    Katowice, 41-500
    Poland

    Site Not Available

  • Pratia Onkologia Katowice

    Katowice 3096472, 41-500
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Pozna?, 60-569
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku

    Pozna?, 60-569
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna, 60-569
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Późna 7534652, 60-569
    Poland

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron; Servicio de Hematologia

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon; Servicio de Hematología

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid 3117735, 28009
    Spain

    Site Not Available

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

    London, W1T 7HA
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust

    London 2643743, W1T 7HA
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Sutton, SW3 6JJ
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital; Academic Dept of Haematology

    Sutton, SW3 6JJ
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Sutton 2636503, SW3 6JJ
    United Kingdom

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope - Lennar Foundation Cancer Center

    Irvine, California 92618
    United States

    Site Not Available

  • City of Hope

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • City of Hope - Lennar Foundation Cancer Center

    Irvine 5359777, California 5332921 92618
    United States

    Site Not Available

  • Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Karmanos Cancer Institute.

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Karmanos Cancer Institute.

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

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