Newly diagnosed Multiple Myeloma in patients eligible for stem cell transplantation
Conditions
Brief summary
Cumulative MRD negativity by NGS at a sensitivity level of 10^-6 before start of maintenance therapy.
Detailed description
Sustained (≥12 months) cumulative MRD-negative CR rate (10^-6) by NGS up to 24 months of maintenance therapy., The cumulative rate of the composite endpoint of events (within 24 months of maintenance therapy) per patient and month of therapy. Events of relevance include: Grade 3 or Grade 4 infection; Pause of more than 62 days of all study treatments considering death, progression, and discontinuation of all treatments.
Interventions
DRUGteclistamab
DRUGVELCADE 3.5 mg powder for solution for injection
DRUGDARZALEX 1800 mg solution for injection
DRUGDEXAMETHASONE
Sponsors
Universitaetsklinikum Heidelberg AöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative MRD negativity by NGS at a sensitivity level of 10^-6 before start of maintenance therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sustained (≥12 months) cumulative MRD-negative CR rate (10^-6) by NGS up to 24 months of maintenance therapy., The cumulative rate of the composite endpoint of events (within 24 months of maintenance therapy) per patient and month of therapy. Events of relevance include: Grade 3 or Grade 4 infection; Pause of more than 62 days of all study treatments considering death, progression, and discontinuation of all treatments. | — |
Outcome results
None listed