Phase
Condition
Cancer
Lymphoproliferative Disorders
Multiple Myeloma
Treatment
IGI, 10%
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participants must have a documented diagnosis of Multiple Myeloma (MM) accordingto the guidelines by the International Myeloma Working Group (IMWG) beforeenrollment.
Participant who recently started teclistamab within the first 8 weeks of theirplanned treatment schedule and are planned to receive teclistamab for the next 12months.
The participant or the participant's legally acceptable representative has providedinformed consent (that is, in writing, documented via a signed and dated InformedConsent Form [ICF]) and any required privacy authorization before the initiation ofany study procedures.
The participant is at least 18 years of age at the time of signing the ICF.
If a person of childbearing potential engages in sexual relations that carry risk ofpregnancy, they agree to the following for the period from screening until 30 daysafter the last dose of study drug:
To use a highly effective contraceptive method.
To avoid donating ova.
Exclusion
Exclusion Criteria:
The participant has not achieved at least a minimal response to teclistamab within 8weeks during the screening period.
The participant has a current serious infection or greater than (>) 1 seriousinfection in the past 3 months before screening.
The participant has a documented polyclonal IgG level less than (<) 150 milligramsper deciliter (mg/dL) at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator according to the site's standardpractice.
The participant is currently receiving immunoglobulin products or has receivedimmunoglobulin products within 16 weeks before screening.
The participant has received a hyperimmune or specialty high-titer immunoglobulinproduct (example, cytomegalovirus immune globulin, varicella-zoster immune globulin,hepatitis B immune globulin) within 30 days before screening.
The participant has received live viral vaccines within 30 days before screening.
The participant has an Eastern Cooperative Oncology Group performance status scoreof >2.
The participant has an active viral or bacterial infection or symptoms/signs of suchan infection requiring treatment with anti-infectives within 1 week beforeenrollment.
The participant has received other B Cell Maturation Antigen (BCMA)*Cluster ofDifferentiation (CD3)-directed Bispecific Antibody therapy any time beforescreening.
The participant is scheduled to undergo plasmapheresis during the course of study orhas undergone plasmapheresis in the last 16 weeks before screening.
The participant may be excluded from the study if, in the opinion of theinvestigator, the participant is at high risk for symptomatic hyperviscositysyndrome.
The participant has major surgery scheduled during the study, or the participant hasnot fully recovered from a recent major surgery (as judged by the investigator)during screening (participants with planned surgical procedures to be conductedunder local anesthesia may participate).
The participant has an active secondary (non-MM) malignancy or other medicalcondition with life-expectancy of less than (<) 2 years.
The participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) afterIntravenous Immunoglobulin (IVIG) and/or immune serum globulin infusions.
The participant has a known history or current diagnosis of thromboembolic episodessuch as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemicstroke, transient ischemic attack, peripheral artery disease within 6 months beforescreening.
The participant has moderate to severe renal dysfunction based on an estimatedglomerular filtration rate less than or equal to (<=) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), as defined by kidney disease: Improving GlobalOutcomes Clinical Practice Guideline for the Management of Glomerular Diseases, 2021at the time of screening.
The participant has a known history of or is positive at screening for one or moreof the following: hepatitis B surface antigen, Polymerase Chain Reaction (PCR) forhepatitis C virus, PCR for Human Immunodeficiency Virus (HIV) Type 1 and Type 2.Cured participants with a history of hepatitis C infection who have a negative PCRtest at screening are eligible.
The participant has a documented diagnosis of a form of primary immunodeficiency (PID) involving a defect in antibody formation and requiring IgG replacement, asdefined according to the International Union of Immunological Societies Committee.
The participant has a persistent serum aspartate aminotransferase and alanineaminotransferase >3.0 times the upper limit of normal at screening (may be repeatedonce to determine if it is persistent).
The participant has an immunoglobulin A (IgA) deficiency (<0.07 grams per liter [g/L]) with antibodies to IgA and a history of hypersensitivity reaction to IVIG.
Participant with a known systemic hypersensitivity to any of the excipients of IGI, 10% in accordance with the investigator's brochure/package insert/Summary of ProductCharacteristics.
Known substance abuse including opiates, psychostimulant agents, or other illicitdrugs with the exception of cannabinoids within 12 months of screening.
The participant has anemia that would preclude phlebotomy for laboratory studies,according to standard practice at the site, at the discretion of the investigator (may be repeated once to determine if it has resolved).
The participant has a medical condition, laboratory finding, or physical examinationfinding that precludes participation or with clinical evidence of any significantacute or chronic disease that, in the opinion of the investigator, may interferewith the successful completion of the study or place the participant at unduemedical risk.
The participant is receiving immunosuppressive treatment (other than for MM orcorticosteroids) at screening or plans to receive immunosuppressive treatment afterstudy enrollment.
The participant or the participant's legally designated representative is notwilling and able to comply with the protocol requirements.
The participant has participated or is scheduled to participate in another clinicalstudy involving an investigational product (IP) or investigational device within 30days before screening and during the course of the study.
The participant is a family member or employee of the investigator or theinvestigator's site staff.
The participant is pregnant or has a positive pregnancy test or is lactating at thetime of screening or enrollment.
Study Design
Connect with a study center
St George Private Hospital
Kogarah, New South Wales 2217
AustraliaActive - Recruiting
St George Private Hospital
Kogarah 2161185, New South Wales 2155400 2217
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch, Western Australia 6150
AustraliaActive - Recruiting
Fiona Stanley Hospital
Murdoch 8349091, Western Australia 2058645 6150
AustraliaSite Not Available
Universitaetsklinikum St. Poelten
Sankt Pölten, 3100
AustriaActive - Recruiting
Krankenhaus der Barmherzigen Schwestern Wien
Vienna, 1060
AustriaActive - Recruiting
St. Antonius Ziekenhuis
Nieuwegein, 3435
NetherlandsActive - Recruiting
Aidport sp. z o.o.
Skorzewo, 60-185
PolandActive - Recruiting
University Hospitals Birmingham NHS Foundation Trust
Edgbaston, Birmingham B15 2GW
United KingdomSite Not Available
Northwest Anglia Foundation Trust
Peterborough 2640354, Cambridgehsire PE39GZ
United KingdomSite Not Available
Royal Devon And Exeter Hospital
Exeter, Devon EX2 5DH
United KingdomSite Not Available
Royal Devon And Exeter Hospital
Exeter 2649808, Devon EX2 5DH
United KingdomSite Not Available
Colchester General Hospital
Colcester, Essex CO4 5JL
United KingdomSite Not Available
Colchester General Hospital
Colchester 2652618, Essex CO4 5JL
United KingdomSite Not Available
Gloucestershire Royal Hospital
Gloucester, Gloucestershire GL1 3NN
United KingdomActive - Recruiting
Gloucestershire Royal Hospital
Gloucester 2648404, Gloucestershire GL1 3NN
United KingdomSite Not Available
Cardiff & Vale University Health Board
Cardiff, South Glamorgan CF14 4XU
United KingdomActive - Recruiting
Cardiff & Vale University Health Board
Cardiff 2653822, South Glamorgan CF14 4XU
United KingdomSite Not Available
Harrogate and District NHS Foundation Trust
Harrogate, HG2 7SX
United KingdomSite Not Available
Harrogate and District NHS Foundation Trust
Harrogate 2647428, HG2 7SX
United KingdomSite Not Available
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes, MK6 5LD
United KingdomSite Not Available
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes 2642465, MK6 5LD
United KingdomSite Not Available
County Hospital (Stafford Hospital)
Stafford, ST16 3SA
United KingdomActive - Recruiting
County Hospital (Stafford Hospital)
Stafford 2637142, ST16 3SA
United KingdomSite Not Available
Somerset NHS Foundation Trust
Taunton, TA15DA
United KingdomSite Not Available
Infirmary Health - Diagnostic & Medical Clinic (DMC)
Mobile, Alabama 36604
United StatesActive - Recruiting
Infirmary Health - Diagnostic & Medical Clinic (DMC)
Mobile 4076598, Alabama 4829764 36604
United StatesSite Not Available
Chao Family Comprehensive Cancer Center UCI
Orange, California 92868
United StatesActive - Recruiting
Chao Family Comprehensive Cancer Center UCI
Orange 5379513, California 5332921 92868
United StatesSite Not Available
University of Kansas
Westwood, Kansas 66205
United StatesActive - Recruiting
University of Kansas
Westwood 4281639, Kansas 4273857 66205
United StatesSite Not Available
University of Maryland | Greenebaum Cancer Center
Baltimore, Maryland 21201
United StatesActive - Recruiting
University of Maryland | Greenebaum Cancer Center
Baltimore 4347778, Maryland 4361885 21201
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesActive - Recruiting
Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63141
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63141
United StatesActive - Recruiting
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63141
United StatesSite Not Available
New York Oncology Hematology
Albany, New York 12208
United StatesActive - Recruiting
New York Oncology Hematology
Albany 5106834, New York 5128638 12208
United StatesSite Not Available
East Carolina University
Greenville, North Carolina 27834
United StatesSite Not Available
East Carolina University
Greenville 4469160, North Carolina 4482348 27834
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available

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