Myeloma Multiple, Myeloma
Conditions
Brief summary
This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.
Interventions
DRUGEtentamig
Administered per the protocol
DRUGIsatuximab
Administered per the protocol
Administered per the protocol
Sponsors
Universitätsklinikum Hamburg-Eppendorf
AbbVie
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria. * Participants must have High-risk myeloma according to IMS/IMWG CGS * Participants must be considered a candidate for high-dose chemotherapy and ASCT, as described in the protocol. * Participants must have measurable disease as defined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions). * Participants must have clinical laboratory values within a prespecified range.
Exclusion criteria
* Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment. * known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia * Administration of systemic therapy for multiple myeloma except osteoprotective therapy. Emergency myeloma treatment with dexamethasone is allowed according to specifications in the protocol. It is allowed to include patients after 1 cycle of any anti-myeloma first-line treatment within the specifications of the protocol * known central nervous system involvement by MM.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability (Phase I) | through induction treatment, on average 4 months | Number of dose-limiting toxicities (DLTs) in participants and rates of adverse events (AEs) of grade ≥2 and of severe AEs in participants |
| MRD negativity (Phase II) | through consolidation phase completion, an average of 1 year | MRD-negativity rate after 12 cycles (with a sensitivity of \<10-5) |
| PFS | up to 10 years | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 10 years | Overall response rate |
| CR rate | up to 10 years | Complete Response Rate |
| VGPR Rate | up to 10 years | Very good partial response rate |
| DoR | up to 10 years | Duration of Response |
| TTR | up to 10 years | Time to response |
| PFS2 | up to 10 years | Progression free survival 2 |
| OS | up to 10 years | Overall survival |
| MRD negativity | up to 10 years | Minimal Residual Disease (MRD) Negativity Rate (10-5 to 10-6) |
| Sustained MRD | up to 10 years | Sustained MRD negativity rate (for a duration of 6-months, and multiples therof) |
| MRD-negative CR | up to 10 years | Rates of MRD-negative Complete Responses |
| Sustained MRD-negative CR | up to 10 years | Rate of Sustained MRD-negative Complete Response |
Countries
Germany
Contacts
CONTACTKatja Weisel
CONTACTLisa Leypoldt
Outcome results
None listed