Actively Recruiting
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
Led by SCRI Development Innovations, LLC · Updated on 2026-04-22
100
Participants Needed
17
Research Sites
205 weeks
Total Duration
On this page
Sponsors
S
SCRI Development Innovations, LLC
Lead Sponsor
J
Johnson & Johnson
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
CONDITIONS
Official Title
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older at the time of informed consent
- Have a documented diagnosis of multiple myeloma according to IMWG criteria
- For Teclistamab or Talquetamab with Tocilizumab: have received 2 or more prior multiple myeloma therapies including a proteasome inhibitor, immunomodulatory drug, and CD38 antibody
- For Teclistamab with Oral Dexamethasone: have received 1 or more prior multiple myeloma therapies including a proteasome inhibitor, immunomodulatory drug, and/or CD38 antibody
- Have an ECOG performance status of 0 to 1 for Teclistamab or Talquetamab with Tocilizumab, or 0 to 2 for Teclistamab with Oral Dexamethasone
- Have measurable disease at screening defined by specific serum or urine markers or plasmacytomas
- HIV-positive participants are eligible if viral load is undetectable, CD4 count is above 300 cells/mm3, no recent AIDS-defining infections, and on stable antiretroviral therapy
- Have adequate organ function
- Body weight greater than 35 kg
- Female participants of childbearing potential must have negative pregnancy tests and agree to contraception
- Agree to study procedures and sign informed consent
- Stay within specified travel times and have a competent adult companion during step-up dosing periods
- Agree to carry study ID card and comply with monitoring requirements including twice daily temperature and oxygen saturation checks during first two cycles
- Participant and companion must be aware of signs and symptoms of treatment-related toxicities
You will not qualify if you...
- Have rapidly progressing disease
- Have plasma cell leukemia, Waldenstr�f6m's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
- Have active central nervous system involvement or meningeal signs of multiple myeloma
- Have risk factors for tumor lysis syndrome requiring special management
- Have myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma, except certain low-risk cancers
- Have grade 3 or higher hematologic or clinically significant non-hematologic adverse events
- Have fever or active bacterial, viral, or uncontrolled fungal infection at enrollment
- Have active autoimmune disease or history of autoimmune disease except specified exceptions
- Have significant bleeding risk due to coagulopathy
- Show deterioration in neurological or mental status
- Have psychiatric disorders or cognitive impairments affecting consent or compliance
- History of stroke, transient ischemic attack, or seizure within 6 months
- Have serious cardiac conditions including heart failure, recent myocardial infarction, arrhythmias, or uncontrolled coronary disease
- Have hepatitis B or active hepatitis C infection without viral clearance
- Have chronic obstructive pulmonary disease with low lung function
- Have severe kidney impairment or dialysis dependence
- Have other medical conditions that impair study participation or treatment tolerance
- For Talquetamab arm only: prior severe cytokine release syndrome from T-cell therapies or prior GPRC5D-targeting therapy
- Recent blood transfusions within 7 days
- Contraindications to tocilizumab or IVIG
- Recent live vaccines within 1 month before screening or planned during study
- Recent participation in other investigational drug or device studies
- Recent prior anti-cancer therapies within specified washout periods
- Recent stem cell transplant within specified timeframes with immunosuppressive status requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Arizona Oncology Associates
Tucson, Arizona, United States, 85711
Actively Recruiting
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
3
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
Actively Recruiting
4
Medical Oncology Hematology Consultants
Newark, Delaware, United States, 19713
Actively Recruiting
5
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746
Withdrawn
6
Maryland Oncology Hematology
Columbia, Maryland, United States, 21044
Actively Recruiting
7
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
8
Virginia Oncology Associates
Elizabeth City, North Carolina, United States, 27909
Actively Recruiting
9
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
Actively Recruiting
10
Oncology Associates of Oregon
Eugene, Oregon, United States, 97401
Actively Recruiting
11
TriStar Bone Marrow Transplant
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
Vanderbilt- Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
Texas Oncology
Austin, Texas, United States, 78705
Actively Recruiting
14
Texas Oncology - San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
15
Texas Oncology - Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
16
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
17
Blue Ridge Cancer Center
Roanoke, Virginia, United States, 24014
Actively Recruiting
Research Team
S
Sarah Cannon Development Innovations, LLC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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