Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma

In brief

This is Phase 2, open-label, multicentre, non-randomised study evaluating participants with newly diagnosed MM eligible for high-dose therapy. The goal of the study is to determine if consolidation with T-cell redirectors - Talquetamab and Teclistamab in sequence will improve the response depth: increase MRD negative CR rate.

Key facts

Study ID: NCT06505369
Run by: North Estonia Medical Centre
People needed: 50
Starts: 2024-06-19
Expected to finish: 2028-10-01
Last updated by the study team: 2024-07-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant must have documented MM satisfying the IMWG criteria.
Newly diagnosed patients eligible for high dose therapy and ASCT.
ECOG performance status score ≤2.
HIV-positive participants are eligible if they meet all of the following
No detectable viral load (ie, <50 copies/mL) at screening
CD4+ count >300 cells/mm3 at screening
No AIDS-defining opportunistic infection within 6 months of screening
Receiving HAART. Any changes in HAART due to resistance/progression should occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening.
Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
Willing and able to adhere to the lifestyle restrictions specified in this protocol.
A female participant of childbearing potential must have a negative highly sensitive serum (β hCG) pregnancy test at screening
A female participant must be
Not of childbearing potential or
Of childbearing potential and practicing true abstinence; or have a sole partner who is vasectomized; or practicing 2 effective methods of contraception
A female participant must agree not to donate eggs or freeze for future use during the study and for 6 months after receiving the last dose of study treatment.
A male participant must wear a condom when engaging any sexual activity that allows for passage of ejaculate to another person during the study and for a minimum of 100 days after receiving the last dose of study treatment.
A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 100 days after receiving the last dose of study treatment.
Have clinical laboratory values meeting the following criteria
Hemoglobin ≥8 g/dL
Platelets ≥75×109/L
ANC ≥1.0×109/L
AST and ALT ≤2.5×ULN
eGFR ≥30 mL/min
Total bilirubin <1.5×ULN

You may not qualify if…

Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis.
Known active CNS involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain MRI and lumbar cytology are required.
Peripheral neuropathy or neuropathic pain Grade 2 or higher
Excluded for any of the following:
Any ongoing myelodysplastic syndrome or B cell malignancy (other than MM).
Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy.
Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:
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-hormonal 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's medical monitor.
Stroke within 6 months prior to signing ICF.
Presence of the following cardiac conditions:
New York Heart Association stage III or IV congestive heart failure (see Appendix )
Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina)
Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities
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
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, such as:
Uncontrolled diabetes
Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy
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
Gastrointestinal disease that may significantly alter the absorption of oral drugs

Where it is running

North Estonia Medical Centre — Tallinn, Estonia (enrolling)
Odense University Hospital — Odense, Denmark
Vejle hospital — Vejle, Denmark
Copenhagen University Hospital (Rigshospitalet) — Copenhagen, Denmark
Oslo University Hospital, Oslo Myeloma Centre — Oslo, Norway
Stavanger University Hospital — Stavanger, Norway
St. Olavs Hospital — Trondheim, Norway

Full record on ClinicalTrials.gov

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