USO 25023
Frontline T-cell engager vs Autologous Stem cell Transplant and measurable residual disease (MRD)-guided sequential intensification thERapy in multiple myeloma (FASTER) (MM 195)
Disease Types: Multiple Myeloma, Cellular & Gene
Eligibility Requirements:
Age >18 years with no upper age limit.
Newly diagnosed multiple myeloma with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.
Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR).
Measurable disease
Have trackable clonogenic sequence using ClonoSEQ® (Seattle, WA) identified from a high disease burden sample obtained as SoC and enabling MRD testing during screening phase.
Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment:
Achievement of at least PR to induction therapy, without prior progression of disease.
Prior completion of standard of care mobilization and collection of stem cells (minimum 2 × 106 CD34+ cells/kg) without use of chemotherapy mobilization, any time prior to or during screening phase.
A woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.
A woman must be not of childbearing potential, or of childbearing potential and practicing true abstinence; or have a sole partner who is vasectomized or Practicing ≥1 highly-effective, user-independent method of contraception. NOTE: Participant must agree to continue the above throughout the study and for 4 months after the last dose of study treatment. If a woman becomes of childbearing potential after start of the study the woman must comply with point mentioned in full description located below in CLICK HERE.
NOTE: If the male participant is vasectomized, he still must wear a condom (with or without spermicidal foam/gel/film/cream/suppository), but his female partner is not required to use contraception. For more detailed information see the CLICK HERE below.
For more details on this trial CLICK HERE .
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