Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma

In brief

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients

Key facts

Study ID: NCT05972135
Run by: SCRI Development Innovations, LLC
People needed: 100
Starts: 2023-10-23
Expected to finish: 2027-10-01
Last updated by the study team: 2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Be ≥18 years of age (or the higher legal age in the jurisdiction in which the study is taking place) at the time of informed consent
Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011).
Teclistamab or Talquetamab + Tocilizumab: has received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody.
Teclistamab + Oral Dexamethasone: has received 1 or more prior MM therapies including a PI, IMiD and/or CD38 antibody.
Teclistamab or Talquetamab + Tocilizumab: has an ECOG performance status (Oken 1982) of 0 to 1.
Teclistamab + Oral Dexamethasone: has an ECOG performance status (Oken 1982) of 0 to 2.
Measurable disease at screening, as assessed by local laboratory, defined by any of the following:
Serum M-protein level ≥0.5 g/dL; or
Urine M-protein level ≥200 mg/24 hours; or
Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm).
Human immunodeficiency virus-positive participants are eligible if they meet all of the following:
No detectable viral load (i.e., <50 copies/mL) at screening
CD4+ count >300 cells/mm3 at screening
No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening
Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance/progression should occur at least 3 months prior to enrollment. A change in HAART due to toxicity is allowed up to 4 weeks prior to enrollment.
Adequate organ system function
Body weight >35 kg.
A participant of childbearing potential must have a negative highly sensitive serum (β-hCG) at screening and within 72 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.
A participant must agree to abide by protocol defined contraceptive requirements for the duration of the study including avoiding donating gametes for specified period of time.
A participant must sign an ICF indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
A participant is required to stay within 60 minutes of transportation to the site and remain in the company of a competent adult at all times until 48 hours following administration of all doses within the teclistamab step-up dosing schedules
A participant is required to stay within 30 minutes of transportation to the site and remain in the company of a competent adult at all times until 48 hours following administration of all doses within the talquetamab step-up dosing schedule
A participant must agree to carry the study participant identification wallet card at all times.
A participant must comply with all the protocol requirement procedures, including measuring and recording of body temperature and blood oxygen saturation twice daily (≥8 hours apart) during the first 2 cycles of teclistamab or talquetamab treatment and coming to the study site for safety assessments.

You may not qualify if…

Has a rapidly progressing disease per investigator assessment.
Has plasma cell leukemia (>2.0×10\^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
Has known active CNS involvement or exhibits clinical signs of meningeal involvement of MM.
Has risk factors for developing clinically significant TLS and requiring management with increased hydration, allopurinol, or rasburicase.
Has myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:
Any malignancy that was not progressing nor requiring treatment change in the last 12 months.
Malignancies treated within the last 12 months and considered at very low risk for recurrence:
Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, <3 cm, no CIS).
Skin cancer (non-melanoma or melanoma).
Noninvasive cervical cancer.
Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.
Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment).
Other malignancy that is considered at minimal risk of recurrence.
Has Grade ≥3 hematologic AEs or Grade ≥3, clinically significant non-hematologic AEs.
Has fever or active infection (bacterial, viral, or uncontrolled systemic fungal) at time of study enrollment.
Has active autoimmune disease or a documented history of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing.
Has clinically significant coagulopathy that would increase the risk of bleeding in the setting of cytopenia.
Shows a deterioration in neurologic status, including mental status changes such as confusion or increased somnolence.
Has psychiatric disorders (eg, alcohol or drug abuse), dementia, or altered mental status that would compromise the ability to provide informed consent or comply with the clinical protocol.
History of stroke, transient ischemic attack or seizure within 6 months of signing ICF.
Presence of the following cardiac conditions:
New York Heart Association stage III or IV congestive heart failure.
Myocardial infarction or CABG ≤6 months prior to enrollment.
History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.
History of severe non-ischemic cardiomyopathy.

Where it is running

Blue Ridge Cancer Center — Roanoke, Virginia, United States (enrolling)
Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
Rocky Mountain Cancer Center — Denver, Colorado, United States (enrolling)
Medical Oncology Hematology Consultants — Newark, Delaware, United States (enrolling)
Arizona Oncology Associates — Tucson, Arizona, United States (enrolling)
Maryland Oncology Hematology — Columbia, Maryland, United States (enrolling)
Minnesota Oncology Hematology — Minneapolis, Minnesota, United States (enrolling)
Virginia Oncology Associates — Elizabeth City, North Carolina, United States (enrolling)
Oncology Hematology Care — Cincinnati, Ohio, United States (enrolling)
Oncology Associates of Oregon — Eugene, Oregon, United States (enrolling)
TriStar Bone Marrow Transplant — Nashville, Tennessee, United States (enrolling)
Vanderbilt- Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
Texas Oncology — Austin, Texas, United States (enrolling)
Texas Oncology - San Antonio — San Antonio, Texas, United States (enrolling)
Texas Oncology - Northeast Texas — Tyler, Texas, United States (enrolling)
Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
Florida Cancer Specialists — Lake Mary, Florida, United States

Full record on ClinicalTrials.gov

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