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Myeloma drugs tested for home use: could cut hospital stays

NCT ID NCT05972135

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether two drugs, teclistamab and talquetamab, can be given safely in an outpatient setting for people with multiple myeloma. The study will enroll 100 participants who have already tried other treatments. The main goal is to see how often side effects like cytokine release syndrome (CRS) occur when preventive medicines are used, with the hope of making treatment more convenient.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Teclistamab or Talquetamab (drugs given as shots under the skin)
What this could lead to
If successful, this could allow multiple myeloma patients to receive these powerful drugs safely as outpatients, reducing time in the hospital.
What could go wrong
This is a small, early-phase study (100 people) focused on safety and side effects, not yet on cure. Side effects like cytokine release syndrome (CRS) are still a risk, even with preventive medicines.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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). * 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. * A participant and the accompanying competent adult must be made aware of the presenting sign sand symptoms of teclistamab- or talquetamab- associated toxicities, including but not limited to CRS, ICANS, infections, etc. The accompanying competent adult must watch the participant at all times for teclistamab- or talquetamab- associated toxicities, until 48 hours after the first treatment dose of teclistamab or talquetamab. Exclusion Criteria: * 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. * Poorly controlled coronary artery disease and/or congestive heart failure. * Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities. * Has hepatitis B infection (ie, HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status. * Has active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study. * Has COPD with FEV1 \<50% of predicted. * Has eGFR \<20 ml/min or is dependent on dialysis. * Has other medical issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. * For talquetamab arm only: Prior Grade 3 or higher CRS related to any T-cell redirection (e.g., CD-3 redirection technology or CAR-T cell therapy), or any prior GPRC5D-targeting therapy. * Has received packed RBC or platelet transfusions within the last 7 days prior to dosing. * Has contraindications to the use of tocilizumab or IVIG per local prescribing information. * Has received live vaccine(s) within 1 month prior to screening or plans to receive live vaccines during the study. * Has received live, attenuated vaccine(s) within 30 days before the first dose of teclistamab or talquetamab. Live, attenuated influenza vaccines are permitted as late as 30 days before the study treatment. * Has received any non-anti-cancer investigational intervention or used any non-anti-cancer invasive investigational medical device within 21 days before the planned first dose of study treatment or received any non-anti-cancer investigational biological product within 21 days or 5 half-lives, whichever is shorter, before the planned study treatment, or is currently enrolled in an investigational study. * History of prior anti-cancer therapy as follows, before the first dose of study drug: * Targeted therapy, epigenetic therapy, or treatment with an investigational anti-cancer drug or used an invasive investigational medical device within 21 days or 5 half-lives, whichever is shorter. * Monoclonal antibody treatment for MM within 21 days. * Cytotoxic therapy within 21 days. * PI therapy within 14 days. * Immunomodulatory agent therapy within 7 days. * Radiotherapy within 14 days or focal radiation within 7 days. * For teclistamab arms only: Prior Gene modified adoptive cell therapy (eg, chimeric antigen receptor modified \[CAR\]-T cells, NK cells, or BCMA therapy) * For talquetamab arm only: Prior CAR-T or BCMA bispecific antibody therapy are allowed with the appropriate wash-out period: 1) Gene modified adoptive cell therapy (eg, chimeric antigen receptor modified \[CAR\]-T cells, NK cells) within 3 months, or 2) BCMA therapies (antibody-drug conjugates and bispecific antibodies, etc) within 21 days or at least 5 half-lives, whichever is less. * History of stem cell transplant: * An allogeneic stem cell transplant within 6 months. Participants who received an allogeneic transplant must be off all immunosuppressive medications for ≥42 days without signs of graft-versus-host disease. * An autologous stem cell transplant ≤12 weeks before the first dose of study drug.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona Oncology Associates

    RECRUITING

    Tucson, Arizona, 85711, United States

  • Blue Ridge Cancer Center

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Florida Cancer Specialists

    WITHDRAWN

    Lake Mary, Florida, 32746, United States

  • Maryland Oncology Hematology

    RECRUITING

    Columbia, Maryland, 21044, United States

  • Medical Oncology Hematology Consultants

    RECRUITING

    Newark, Delaware, 19713, United States

  • Minnesota Oncology Hematology

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Oncology Associates of Oregon

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Oncology Hematology Care

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Rocky Mountain Cancer Center

    RECRUITING

    Denver, Colorado, 80218, United States

  • Texas Oncology

    RECRUITING

    Austin, Texas, 78705, United States

  • Texas Oncology - Northeast Texas

    RECRUITING

    Tyler, Texas, 75702, United States

  • Texas Oncology - San Antonio

    RECRUITING

    San Antonio, Texas, 78240, United States

  • TriStar Bone Marrow Transplant

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Vanderbilt- Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    RECRUITING

    Elizabeth City, North Carolina, 27909, United States

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