Multiple MyelomaPhase 2NCT05972135
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
A Phase 2 study testing Teclistamab, Talquetamab and Tocilizumab in people with Multiple Myeloma, run by SCRI Development Innovations, LLC at 17 sites in United States.
Trial summary
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Teclistamab, Talquetamab and Tocilizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 17 sitesUnited States
- Study dates
- 23 Oct 2023to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 16 recruiting
- Recruiting
Texas Oncology
Austin, Texas, 78705
- Recruiting
Oncology Hematology Care
Cincinnati, Ohio, 45242
- Recruiting
Maryland Oncology Hematology
Columbia, Maryland, 21044
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Recruiting
Rocky Mountain Cancer Center
Denver, Colorado, 80218
- Recruiting
Virginia Oncology Associates
Elizabeth City, North Carolina, 27909
- Recruiting
Oncology Associates of Oregon
Eugene, Oregon, 97401
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Withdrawn
Florida Cancer Specialists
Lake Mary, Florida, 32746
- Recruiting
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404
- Recruiting
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
- Recruiting
Vanderbilt- Ingram Cancer Center
Nashville, Tennessee, 37232
- Recruiting
Medical Oncology Hematology Consultants
Newark, Delaware, 19713
- Recruiting
Blue Ridge Cancer Center
Roanoke, Virginia, 24014
- Recruiting
Texas Oncology - San Antonio
San Antonio, Texas, 78240
- Recruiting
Arizona Oncology Associates
Tucson, Arizona, 85711
- Recruiting
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
About this study
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
Read the detailed description
- This is a three-arm, non-randomized, multicenter, prospective study in adult patients with RRMM, who are administered Teclistamab (TECVAYLI™) or Talquetamab (TALVEY™), in the post-marketing setting.
- Teclistamab (TECVAYLI™) is a humanized IgG-4 PAA bispecific antibody designed to target the CD3 receptor complex on T cells and BCMA on B-lineage cells.
- Talquetamab (TALVEY™) is a humanized IgG-4 bispecific antibody designed to target the CD3 receptor complex on T cells and GPRC5D-expressing multiple myeloma (MM) cells This study will investigate the use of prophylactic tocilizumab or prophylactic dexamethasone to reduce the incidence and severity of CRS associated with teclistamab or talquetamab administration, to enable administration of the step-up dosing regimen of teclistamab or talquetamab in an outpatient setting.
- Conditions
- Multiple Myeloma
- Being tested
- Teclistamab, Talquetamab, Tocilizumab, Oral Dexamethasone
- Keywords
- Teclistamab (TECVAYLI™), Humanized IgG-4 PAA bispecific antibody, CD3 receptor complex, RRMM-Relapsed or Refractory Multiple Myeloma, MM-Multiple Myeloma, Tocilizumab prophylaxis, CRS- Cytokine Release Syndrome, Neurologic toxicity, ICANS-Immune Effector Cell-associated Neurotoxicity Syndrome, Talquetamab (TALVEY™), GPRC5D, BCMA, Oral dexamethasone prophylaxis
- Medical subject headings
- Multiple Myeloma, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
Also called (TECVAYLI™)
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.
TalquetamabDrug
Also called TALVEY™
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
TocilizumabDrug
Also called Actemra
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.
Oral DexamethasoneDrug
Also called Decadron
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.
| Study group | Role | What they receive |
|---|---|---|
| Teclistamab/Tocilizumab | Experimental | Participants will receive step up dosing of Teclistamab following the recommended dosage of TECVAYLI™ USPI followed by weekly dosing for twelve 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 2 weeks for participants who achieve partial response (PR) or better after 6 months of therapy. Receives: Drug: Teclistamab; Drug: Tocilizumab |
| Talquetamab/Tocilizumab | Experimental | Participants will receive step up dosing of Talquetamab following the recommended dosage of TALVEY™ USPI followed by every 2 week dosing for six 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 6). Talquetamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better after Cycle 4. Participants in the talquetemab arm cannot be re-screened for or re-enrolled into the teclistamab arm. Receives: Drug: Talquetamab; Drug: Tocilizumab |
| Teclistamab/Oral Dexamethasone | Experimental | Participants will receive step-up dosing of Teclistamab followed by weekly dosing for two cycles, every other week during Cycles 3-6 and once every 4 weeks from Cycles 7 through 12 until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better starting with Cycle 3. Receives: Drug: Teclistamab; Drug: Oral Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CRS of any grade during the first two cycles
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.
Measured: 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)
Secondary outcomes (29)
Incidence of recurrent CRS of any grade
Evaluate the incidence of recurrent CRS either 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.
Measured: 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)
Incidence of CRS of any grade
Evaluate the incidence of CRS 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.
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of recurrent CRS of any grade
Evaluate the incidence of recurrent CRS 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.
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) 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.
Measured: 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)
Incidence of Recurrent Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) 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.
Measured: 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)
Incidence of Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles and throughout the study 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.
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Recurrent Grade ≥2 CRS
Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles and throughout the study 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.
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Grade ≥3 and any grade infections
Evaluate the risk of Grade ≥3 and any grade infections throughout the study based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of All grade and Grade ≥3 neurotoxicity
Evaluate neurotoxicity in the setting of prophylactic tocilizumab or prophylactic oral dexamethasone based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Measured: 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)
Incidence of All grade and Grade ≥3 ICANS
Evaluate neurotoxicity including ICANS in the setting of prophylactic tocilizumab or prophylactic oral dexamethasone based on the American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS (Grade 1 to 4 with grade 4 representing a worse outcome)
Measured: 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)
Incidence of All grade neutropenia and Grade ≥3 neutropenia
Evaluate treatment-emergent neutropenia in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of all grade febrile neutropenia and Grade ≥3 febrile neutropenia
Evaluate treatment-emergent febrile neutropenia in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 (Grade 1 to 5 with grade 5 representing a worse outcome)
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Total length of each hospital stay
Evaluate the length of each hospital stay in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Number of hospitalizations per participant
Evaluate the number of hospitalizations per participant, in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Healthcare resource utilization in the outpatient setting
Monitor the utilization of healthcare resources in the outpatient setting to mitigate the AEs associated with CRS/ICANS in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Measured: 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)
Overall response rate (ORR)
Overall response rate (ORR) will be defined as the proportion of participants who achieve a PR or better response according to the IMWG response criteria
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Time to initial response (TTR)
Time to initial response (TTR) will be defined as the time between the date of the first dose of teclistamab or talquetamab and the first efficacy evaluation that the participants have met all criteria for PR or better response according to the IMWG response criteria
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Time to best response (TTBR)
Time to best response (TTBR) will be defined as the time between the date of the first dose of teclistamab or talquetamab and the first efficacy evaluation that the participants have the best response according to the IMWG response criteria
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Duration of response (DOR)
Duration of response (DOR) will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG response criteria
Measured: Day 1 of every 2 cycles from Cycle 1 Day 1 and up to approximately 12 months of teclistamab treatment or 6 months for talquetamab. (each cycle is 28 days)
Time to next treatment (TTNT)
Time to next treatment (TTNT) is defined as the time from the date of the first dose of teclistamab or talquetamab to the date of next treatment, or death due to any cause, whichever occurs first.
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of the first dose of teclistamab or talquetamab to the date of death, due to any cause.
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of the first dose of teclistamab or talquetamab, to the date of first documented disease progression, as defined in the IMWG response criteria, or death due to any cause, whichever occurs first.
Measured: Day 1 of every 2 cycles From Cycle 1 Day 1 and up to approximately 12 months of teclistamab or 6 months for talquetamab treatment. (each cycle is 28 days)_
Timing of each hospital stay
Evaluate the timing of each hospital stay in the setting of teclistamab or talquetamab plus prophylactic tocilizumab or teclistamab plus prophylactic oral dexamethasone
Measured: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Talquetamab Arm only: Number of participants who have had a change in health-related quality of life parameters, from baseline to end of treatment
Talquetamab Arm only: Assess health-related quality of life parameters related to overall health as well as specific impact of taste changes, xerostomia, dysphagia, oral mucositis, and other aspects of oral toxicity using EORTC-QLQ and Epstein taste scale
Measured: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Number of participants with oral toxicities
Talquetamab Arm only: Assess health-related quality of life parameters related to overall health as well as specific impact of taste changes, xerostomia, dysphagia, oral mucositis, and other aspects of oral toxicity using Epstein taste scale, PRO-CTCAE, STTA and SXI
Measured: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Number of patients with overall side effects
Talquetamab Arm only: Assess health-related quality of life parameters related to overall health as well as specific impact of taste changes, xerostomia, dysphagia, oral mucositis, and other aspects of oral toxicity using PGI-S and EORTC Q168/EORTC-IL46
Measured: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Rate of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Talquetamab Arm only: To assess rate of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Measured: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Time to first onset of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Talquetamab Arm only: To assess time to first onset of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Measured: Up 6 to months for talquetamab treatment
Talquetamab Arm only: Duration of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Talquetamab Arm only: To assess duration of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Measured: Up 6 to months for talquetamab treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start23 Oct 2023
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Peter A. Forsberg, MD, Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972135
- Sponsor's protocol ID
- MM165
- Status last verified
- Apr 2026
- First submitted
- 12 Jul 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05972135
- Acronym / sponsor ID
- MM165
- Conditions
- Multiple Myeloma
- Keywords
- Teclistamab (TECVAYLI™), Humanized IgG-4 PAA bispecific antibody, CD3 receptor complex, RRMM-Relapsed or Refractory Multiple Myeloma, MM-Multiple Myeloma, Tocilizumab prophylaxis, CRS- Cytokine Release Syndrome, Neurologic toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
Detailed description
- This is a three-arm, non-randomized, multicenter, prospective study in adult patients with RRMM, who are administered Teclistamab (TECVAYLI™) or Talquetamab (TALVEY™), in the post-marketing setting.
- Teclistamab (TECVAYLI™) is a humanized IgG-4 PAA bispecific antibody designed to target the CD3 receptor complex on T cells and BCMA on B-lineage cells.
- Talquetamab (TALVEY™) is a humanized IgG-4 bispecific antibody designed to target the CD3 receptor complex on T cells and GPRC5D-expressing multiple myeloma (MM) cells This study will investigate the use of prophylactic tocilizumab or prophylactic dexamethasone to reduce the incidence and severity of CRS associated with teclistamab or talquetamab administration, to enable administration of the step-up dosing regimen of teclistamab or talquetamab in an outpatient setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Teclistamab/Tocilizumab | Experimental | Drug: Teclistamab, Drug: TocilizumabParticipants will receive step up dosing of Teclistamab following the recommended dosage of TECVAYLI™ USPI followed by weekly dosing for twelve 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 2 weeks for participants who achieve partial response (PR) or better after 6 months of therapy. |
| Talquetamab/Tocilizumab | Experimental | Drug: Talquetamab, Drug: TocilizumabParticipants will receive step up dosing of Talquetamab following the recommended dosage of TALVEY™ USPI followed by every 2 week dosing for six 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 6). Talquetamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better after Cycle 4. Participants in the talquetemab arm cannot be re-screened for or re-enrolled into the teclistamab arm. |
| Teclistamab/Oral Dexamethasone | Experimental | Drug: Teclistamab, Drug: Oral DexamethasoneParticipants will receive step-up dosing of Teclistamab followed by weekly dosing for two cycles, every other week during Cycles 3-6 and once every 4 weeks from Cycles 7 through 12 until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better starting with Cycle 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
Key exclusion criteria (50 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeclistamabAlso: (TECVAYLI™)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 | Teclistamab/Oral Dexamethasone, Teclistamab/Tocilizumab |
| TalquetamabAlso: TALVEY™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 | Talquetamab/Tocilizumab |
| TocilizumabAlso: ActemraTocilizumab 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 | Talquetamab/Tocilizumab, Teclistamab/Tocilizumab |
| Oral DexamethasoneAlso: DecadronOral 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. | Drug | Teclistamab/Oral Dexamethasone |
Primary outcome
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.
29 secondary outcomes
Incidence of recurrent CRS of any grade
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)
Incidence of CRS of any grade
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of recurrent CRS of any grade
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Grade ≥2 CRS
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)
Incidence of Recurrent Grade ≥2 CRS
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)
Incidence of Grade ≥2 CRS
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Recurrent Grade ≥2 CRS
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of Grade ≥3 and any grade infections
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of All grade and Grade ≥3 neurotoxicity
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)
Incidence of All grade and Grade ≥3 ICANS
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)
Incidence of All grade neutropenia and Grade ≥3 neutropenia
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Incidence of all grade febrile neutropenia and Grade ≥3 febrile neutropenia
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Total length of each hospital stay
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Number of hospitalizations per participant
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Healthcare resource utilization in the outpatient setting
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)
Overall response rate (ORR)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Time to initial response (TTR)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Time to best response (TTBR)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Duration of response (DOR)
Time frame: Day 1 of every 2 cycles from Cycle 1 Day 1 and up to approximately 12 months of teclistamab treatment or 6 months for talquetamab. (each cycle is 28 days)
Time to next treatment (TTNT)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Overall survival (OS)
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Progression-free survival (PFS)
Time frame: Day 1 of every 2 cycles From Cycle 1 Day 1 and up to approximately 12 months of teclistamab or 6 months for talquetamab treatment. (each cycle is 28 days)_
Timing of each hospital stay
Time frame: Up to 12 months of teclistamab or 6 months for talquetamab treatment
Talquetamab Arm only: Number of participants who have had a change in health-related quality of life parameters, from baseline to end of treatment
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Number of participants with oral toxicities
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Number of patients with overall side effects
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Rate of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Time frame: Up to 6 months for talquetamab treatment
Talquetamab Arm only: Time to first onset of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Time frame: Up 6 to months for talquetamab treatment
Talquetamab Arm only: Duration of treatment-emergent dysgeusia, oral mucositis, dysphagia, and xerostomia
Time frame: Up 6 to months for talquetamab treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter A. Forsberg, MD study chair
SCRI Development Innovations, LLC
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teclistamab, Talquetamab and Tocilizumab in people with Multiple Myeloma, run by SCRI Development Innovations, LLC at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Cannon Development Innovations, LLC (1-844-710-6157, SCRI.InnovationsMedical@scri.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.