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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma (NCT05972135) is a Phase 2 interventional studying Multiple Myeloma, sponsored by SCRI Development Innovations, LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Multiple Myeloma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Multiple Myeloma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Be ≥18 years of age (or the higher legal age in the jurisdiction in which the study is taking place) at the time of willing to sign a consent form - 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 weakened immune system 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 weakened immune system 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (17)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05972135), the sponsor (SCRI Development Innovations, LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05972135 clinical trial studying?

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05972135?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05972135?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05972135. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05972135. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.