NCT05972135 · SCRI Development Innovations, LLC
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
What this study is about
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
View original scientific description
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
Interventions
DRUG
Teclistamab
Teclistamab will be administered subcutaneously at step-up doses on Day 1, Day 4 and Day 8, one week after first treatment dose and weekly thereafter. In participants who have a partial response (PR) or better after 6 months of therapy, dosing frequency may be reduced to every 2 weeks.
DRUG
Talquetamab
Talquetamab will be administered subcutaneously at step-up doses on Day 1, Day 4, Day 8 and Day 15, one week after first treatment dose and every 2 weeks thereafter. In participants who have a very good partial response (VGPR) or better after Cycle 4, dosing frequency may be reduced to every 4 weeks
DRUG
Tocilizumab
Tocilizumab will be administered as a pretreatment medication in advance of administration of the first step-up dose of teclistamab or talquetamab on Cycle 1 Day 1.
DRUG
Oral Dexamethasone
Oral dexamethasone will be administered as a pretreatment medication every 12 hours in 3 doses (PM/AM/PM) following each step-up dose and the first full dose of teclistamab in Cycle 1. A total of 9 doses of oral dexamethasone will be administered.
Primary outcome measures
Incidence of CRS of any grade during the first two cycles
Time frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
Evaluate the overall incidence of CRS in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
- Has received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody.
- Has an ECOG performance status (Oken 1982) of 0 to 1.
- 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 loa
Where
- Tucson, Arizona
- Denver, Colorado
- Newark, Delaware
- Lake Mary, Florida
- Columbia, Maryland
- Minneapolis, Minnesota
- Elizabeth City, North Carolina
- Cincinnati, Ohio
- Eugene, Oregon
- Nashville, Tennessee
- Austin, Texas
- San Antonio, Texas
And 3 more locations — see the full list below.
Collaborators
Johnson & Johnson
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations