Phase
Condition
Lymphoproliferative Disorders
Multiple Myeloma
Cancer/tumors
Treatment
Tocilizumab
Dexamethasone
Pomalidomide
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Peter MacCallum Cancer Centre
Melbourne, Victoria 3002
AustraliaSite Not Available
Peter MacCallum Cancer Centre; Department of Haematology
Melbourne, Victoria 3002
AustraliaSite Not Available
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
The Alfred Hospital; Malignant Haematology & Stem Cell Transplant Service
Melbourne, Victoria 3004
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne 2158177, Victoria 2145234 3002
AustraliaSite Not Available
The Alfred Hospital
Melbourne 2158177, Victoria 2145234 3004
AustraliaSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Cross Cancer Institute
Edmonton 5946768, Alberta 5883102 T6G 1Z2
CanadaSite Not Available
Hamilton Health Sciences
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
University Health Network
Toronto, Ontario M5G 2M9
CanadaSite Not Available
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Hamilton Health Sciences
Hamilton 5969782, Ontario 6093943 L8V 5C2
CanadaSite Not Available
University Health Network
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
Fakultni Nemocnice Ostrava
Ostrava, 708 52
CzechiaSite Not Available
Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU
Ostrava, 708 52
CzechiaSite Not Available
Fakultni Nemocnice Ostrava
Ostrava 3068799, 708 52
CzechiaSite Not Available
I Interni klinika
Prague 2, 128 08
CzechiaSite Not Available
I Interni klinika; Vseobecna fakultni nemocnice
Prague 2, 128 08
CzechiaSite Not Available
Rigshospitalet
København Ø, 2100
DenmarkSite Not Available
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT
København Ø, 2100
DenmarkSite Not Available
Rigshospitalet
København Ø 11746747, 2100
DenmarkSite Not Available
Hôpital Saint-Louis
Paris, 75475
FranceSite Not Available
Hôpital Saint-Louis; Service d'Hématologie
Paris, 75475
FranceSite Not Available
Hôpital Saint-Louis
Paris 2988507, 75475
FranceSite Not Available
CHU de Poitiers - La Miletrie
Poitiers, 86021
FranceSite Not Available
CHU de Poitiers - La Miletrie; Oncologie hematologique - Pole Regional de Cancerologie
Poitiers, 86021
FranceSite Not Available
CHU de Poitiers - La Miletrie
Poitiers 2986495, 86021
FranceSite Not Available
CHU Pontchaillou
Rennes, 35003
FranceSite Not Available
CHU Pontchaillou; Service Hématologie
Rennes, 35003
FranceSite Not Available
Rambam Medical Center
Haifa, 3109601
IsraelSite Not Available
Rambam Medical Center; Heamatology & Bone Marrow Transplantation
Haifa, 3109601
IsraelSite Not Available
Rambam Medical Center
Haifa 294801, 3109601
IsraelSite Not Available
Sourasky Medical Centre
Tel-Aviv, 6423906
IsraelSite Not Available
ASST PAPA GIOVANNI XXIII; Ematologia
Bergamo, Lombardia 24127
ItalySite Not Available
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia, Lombardia 25123
ItalySite Not Available
Asst Papa Giovanni Xxiii
Bergamo, Lombardy 24127
ItalySite Not Available
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy 25123
ItalySite Not Available
Asst Papa Giovanni Xxiii
Bergamo 3182164, Lombardy 3174618 24127
ItalySite Not Available
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia 3181554, Lombardy 3174618 25123
ItalySite Not Available
Nagoya City University Hospital
Aichi, 467-8602
JapanSite Not Available
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
JapanSite Not Available
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
JapanSite Not Available
Yamagata University Hospital
Yamagata, 990-9585
JapanSite Not Available
Yamagata University Hospital
Yamagata 2110556, 990-9585
JapanSite Not Available
Samsung Medical Center
Seoul, 135-710
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Kilnika Hematologii i Transplantologii, Oddzia? Wczesnych Faz
Gda?sk, 80-214
PolandSite Not Available
Pratia Onkologia Katowice
Katowice, 41-500
PolandSite Not Available
Pratia Onkologia Katowice
Katowice 3096472, 41-500
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Poznaniu
Pozna?, 60-569
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku
Pozna?, 60-569
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, 60-569
PolandSite Not Available
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna 7534652, 60-569
PolandSite Not Available
Samsung Medical Center
Seoul, 06351
South KoreaSite Not Available
Seoul National University Hospital
Seoul, 03080
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848, 06351
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, 08035
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona 3128760, 08035
SpainSite Not Available
Hospital General Universitario Gregorio Marañon
Madrid, 28009
SpainSite Not Available
Hospital General Universitario Gregorio Marañon; Servicio de Hematología
Madrid, 28007
SpainSite Not Available
Hospital General Universitario Gregorio Marañon
Madrid 3117735, 28009
SpainSite Not Available
University College London Hospitals NHS Foundation Trust
London, W1T 7HA
United KingdomSite Not Available
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility
London, W1T 7HA
United KingdomSite Not Available
University College London Hospitals NHS Foundation Trust
London 2643743, W1T 7HA
United KingdomSite Not Available
Royal Marsden Hospital
Sutton, SW3 6JJ
United KingdomSite Not Available
Royal Marsden Hospital; Academic Dept of Haematology
Sutton, SW3 6JJ
United KingdomSite Not Available
Royal Marsden Hospital
Sutton 2636503, SW3 6JJ
United KingdomSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
City of Hope - Lennar Foundation Cancer Center
Irvine, California 92618
United StatesSite Not Available
City of Hope
Duarte 5344147, California 5332921 91010
United StatesSite Not Available
City of Hope - Lennar Foundation Cancer Center
Irvine 5359777, California 5332921 92618
United StatesSite Not Available
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
Denver, Colorado 80218
United StatesSite Not Available
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
Denver 5419384, Colorado 5417618 80218
United StatesSite Not Available
Winship Cancer Institute
Atlanta, Georgia 30322
United StatesSite Not Available
Karmanos Cancer Institute.
Detroit, Michigan 48201
United StatesSite Not Available
Karmanos Cancer Institute.
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.