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New treatment option for Multiple Myeloma
Official title Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
ClinicalTrials.gov ID: NCT06993675
What this study is testing
What is Talquetamab?
Talquetamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
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
- Multiple myeloma is characterized by a pattern of recurrent relapse and remains an incurable malignancy. Participants with minimal residual disease (MRD) after front line therapy with induction and transplant have worse prognosis than those with MRD negative disease.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
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
- To qualify for participation in this study, an individual must satisfy each of the following criteria:
- Provision of signed and dated ICF.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 18 years or older.
- Newly diagnosed multiple myeloma participants who are transplant eligible and have completed at least four cycles of quadruplet, anti-CD38...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Prior or concurrent exposure to any of the following within the specified timeframe before first dose of study drug:
- Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5...
- Investigational vaccine within four weeks.
- Monoclonal antibody therapy within 21 days.
- Cytotoxic therapy within 14 days.
See the full eligibility criteria
Who can join
- To qualify for participation in this study, an individual must satisfy each of the following criteria:
- Provision of signed and dated ICF.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 18 years or older.
- Newly diagnosed multiple myeloma participants who are transplant eligible and have completed at least four cycles of quadruplet, anti-CD38 antibody-based induction and have received HDM ASCT within 60-120 days. If...
- Must have MRD positive disease at 10-5 based on NGS with a PR or better response.
- Must not be progressing as per IMWG criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 or 1. ECOG 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior...
- Hemoglobin 8 g/dl (³5mmol/L; without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted).
- Absolute neutrophil count ≥1.0×109/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated-G-CSF).
- Platelets ³75×109/L (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test).
- Estimated creatinine clearance ≥30 mL/min based on the Cockcroft-Gault Equation (see https://www.mdcalc.com/calc/43/creatinine-clearance-cockcroft-gault-equation)
- Must have adequate liver function:
- Aspartate aminotransferase ≤2.5 folds of the upper limit of normal (ULN).
- Alanine aminotransferase ≤2.5 folds of the ULN.
- Serum bilirubin ≤ 1.5 x ULN (except in participants with congenital bilirubinemia, such as Gilbert syndrome where must be \<5xULN).
- Participants must adhere to the following reproductive and contraceptive requirements while on study treatment and for the specified duration after the last dose of talquetamab or teclistamab:
- For participants receiving talquetamab, these criteria apply for three months after the last dose.
- For participants receiving teclistamab, these criteria apply for five months for those assigned female at birth and three months for those assigned male at birth.
- General Requirements: i. Participants must not be pregnant or breastfeeding. ii. Participants must not donate gametes (i.e., eggs or sperm) or freeze gametes for future use related to assisted reproduction. d. For...
What rules you out
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Prior or concurrent exposure to any of the following within the specified timeframe before first dose of study drug:
- Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less.
- Investigational vaccine within four weeks.
- Monoclonal antibody therapy within 21 days.
- Cytotoxic therapy within 14 days.
- PI therapy within 14 days.
- IMiD agent therapy within 14 days.
- Radiotherapy within 14 days or focal radiation within seven days.
- Gene-modified adoptive cell therapy (e.g., NK cells) within three months.
- Prior exposure to a bispecific T-cell engager or CAR T-cell therapy.
- An active or suspected infection at time of screening. For rescreening refer to section 5.5.
- Known history or serologic evidence of human immunodeficiency virus (HIV) infection.
- Known history, virologic, or serological evidence of hepatitis B or C virus (HBV/HCV) infection; participants who had HCV but have received an antiviral treatment and show no detectable HCV viral RNA for six months are...
- Class III or IV congestive heart failure.
- Presence of clinically relevant CNS pathology.
- Another active malignancy that requires treatment.
- Pregnancy or lactation.
- Known allergic reactions to components of talquetamab or teclistamab.
- Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14 days before first dose of study drug.
- Received a live, attenuated vaccine within four weeks before the first dose of study drug.
- Plasma cell leukemia, smoldering multiple myeloma, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis.
- Any active malignancy (i.e., progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are...
- Non-muscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, \<3 cm, no CIS).
- Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone.
- Non-invasive cervical cancer.
- Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (anti-antihormonal therapy is permitted).
- Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment).
- Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor-investigator. NOTE: In the event of any questions, consult with the sponsor-investigator prior to enrolling a...
- Stroke, transient ischemic attack or seizure within six months prior to enrolment.
- Presence of the following cardiac conditions:
- New York Heart Association stage III or IV congestive heart failure (Appendix 5: New York Heart Association Functional Classification).
- Myocardial infarction, unstable angina, or coronary artery bypass graft ≤6 months prior to randomization.
- History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.
- Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities.
- Major surgery within two weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be...
- Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study...
- Acute diffuse infiltrative pulmonary disease
- Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy
- Active autoimmune disease requiring systemic immunosuppressive therapy within six months before start of study treatment. Exception: Participants with vitiligo, controlled type I diabetes, and prior autoimmune thyroid...
- Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status
- Any other 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...
- History of noncompliance with recommended medical treatments.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Rochester, New York, 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
Study sites include New Haven, Connecticut, United States; Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.