The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Teclistamab will be administered via a subcutaneous injection (SC)
Daratumumab will be administered via a subcutaneous injection (SC)
Lenalidomide will be administered orally
Chu Amiens - Hopital Sud
Amiens, France
RECRUITINGChru Angers
Angers, France
RECRUITINGCh D'Avignon
Avignon, France
ACTIVE_NOT_RECRUITINGCentre Hospitalier de La Cote Basque
Bayonne, France
RECRUITINGChu de Besancon
Besançon, France
RECRUITINGAphp Hopital Avicenne
Bobigny, France
NOT_YET_RECRUITINGChu de Caen
Caen, France
RECRUITINGChu Dijon Bourgogne
Dijon, France
RECRUITINGCh de Dunkerque
Dunkirk, France
ACTIVE_NOT_RECRUITINGChu de Grenoble
La Tronche, France
RECRUITING...and 19 more locations
Rate of very good partial response (VGPR) or better according to the IMWG criteria in patients with newly diagnosed multiple myeloma after 4 cycles of treatment with Tec-Dara or Tec-Len
Time frame: At the end of 4 th cycle (each cycle is 28 days), an average 4 months
Treatment-emergent adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 5.0).
Time frame: From date of randomization until the date of first documented progression,assessed up to 5 years
Overall response rate(PR or better) as defined by the IMWG response criteria
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Very good partial response or better, defined as VGPR or CR according to the IMWG criteria at the time of data cutoff
Time frame: TFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Complete response or better, defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow*
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Time to response
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Duration of response
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Time from randomization to discontinuation of therapy for any reason including death, progression or toxicity
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Overall survival time
OS, measured from the date of the first dose of study treatment to the date of the patient's death. If the patient is alive or the vital status is unknown at last contact, then the patient's data will be censored at the date the patient was last known to be alive
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
TTTF, defined as the time from the date of the first dose of study treatment to discontinuation of therapy for any reason including death, progression, toxicity
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
TTNT, defined as the time from date of the first dose of study treatment to the start of the next-line treatmentTime-to-next treatment
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Rate of minimal residual disease (MRD)-negativity (at level of 10-5 and 10-6 by NGS) at 6 months
Time frame: at 6 months
Rate of Sustained MRD-negativity-(at level of 10-5 and 10-6 by NGS)
Time frame: at 18 months (12 months after the initial MRD time point).
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