Clinical trial for Multiple Myeloma
Official title Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
ClinicalTrials.gov ID: NCT05972135
What this study is testing
What is Teclistamab?
an investigational subcutaneous injectable medicine being studied as a potential treatment for multiple myeloma is designed to bind both CD3 on T cells and BCMA on B‑lineage cells, directing immune cells to attack the cancer cells
Also referred to as TECVAYLI™.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study wants to find out if giving these treatments outside of a hospital is safe and works well.
- Who it's for
- People who have multiple myeloma, a type of blood cancer.
- What's involved
- Participants will receive either Teclistamab or Talquetamab in an outpatient setting, which means they do not stay overnight in the hospital.
- Time commitment
- The source text does not specify the total duration or the number of visits required.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
- 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.
- Any malignancy that was not progressing nor requiring treatment change in the last 12 months.
- Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \<3 cm, no CIS).
See the full eligibility criteria
Who can 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.
- 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).
- 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.
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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.
- Any malignancy that was not progressing nor requiring treatment change in the last 12 months.
- 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...
- 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.
- 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Denver, Colorado, United States
- Newark, Delaware, United States
- Columbia, Maryland, United States
- Minneapolis, Minnesota, United States
- Elizabeth City, North Carolina, United States
- Cincinnati, Ohio, United States
- Eugene, Oregon, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Tyler, Texas, United States
- Fairfax, Virginia, United States
- Roanoke, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Denver, Colorado, United States; Newark, Delaware, United States; Columbia, Maryland, United States; Minneapolis, Minnesota, United States; Elizabeth City, North Carolina, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.