Newly Diagnosed Transplant Ineligible Multiple Myeloma
Conditions
Interventions
Drug: Linvoseltamab (Genetical recombination)
Control Arm: DRd until disease progression (PD)
Experimental Arm: linvoseltamab until PD
Sponsors
Sonneveld Pieter
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria. 2. Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol. 3. Participants must have measurable disease as defined in the protocol. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 5. Participants must have clinical laboratory values within a prespecified range.
Exclusion criteria
Exclusion criteria: 1. International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone. 2. Participants who defer transplant due to personal preference. 3. Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenstrom macroglobulinemia, or known POEMS syndrome. 4. Any prior therapy for monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or MM, with the exception of: - focal radiation and/or - a short course of corticosteroids as defined in the protocol. 5. Participants who have received or are receiving any investigational agent or cell therapy with known or suspected activity against MM 6. Participants who have known central nervous system (CNS) or meningeal involvement with MM or known or suspected progressive multifocal leukoencephalopathy (PML), a history of a neurocognitive condition or CNS movement disorder, OR a history of seizure, transient ischemic attack (TIA), stroke or seizure within 12 months prior to study C1D1. 7. Participants who have uncontrolled intercurrent illness. 8. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information. 9. History of allogeneic hematopoietic stem cell transplantation or solid organ transplant at any time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Minimal Residual Disease (MRD): MRD negative Complete Remission (CR) status at 10^-5 per International Myeloma Working Group (IMWG) criteria - MRD negative CR status by BICR: MRD negative CR status at 10^-5 as determined by the Blinded Independent Central Review (BICR) - Progression Free Survival (PFS) per IMWG criteria: defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per IMWG criteria. - PFS as determined by BICR: defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per by BICR. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall Survival (OS): measured from the date of from randomization to the date the subject's death - Objective Response (OR) of Complete Response (CR): To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for CR or better - OR of Very Good Partial Response (VGPR): To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for VGPR or better - OR of Partial Response (PR): To compare the proportion of patients who achieve an objective response per IMWG response criteria between the two study arms for PR or better - Sustained MRD: Sustained MRD negative CR (sMRD) at 10^-5 per IMWG criteria - Duration of response (DOR) of stringent (s)CR: duration of response to best overall response of stringent sCR, per IMWG response criteria - DOR of CR: duration of response to best overall response of CR, per IMWG response criteria - DOR of VGPR: duration of response to best overall response of VGPR, per IMWG response criteria - DOR of PR: duration of response to best overall response of PR, per IMWG response criteria - Time to response >= CR: Time from randomization to objective response (>= CR) as per IMWG response criteria - Time to response >= VGPR: Time from randomization to objective response (>= VGPR) as per IMWG response criteria - Time to response >= PR: Time from randomization to objective response (>= PR) as per IMWG response criteria - Disease progression: Time to disease progression per IMWG response criteria - Incidence of treatment emergent adverse events (TEAEs): Incidence of TEAEs - Severity of TEAEs: Severity of TEAEs - Serious Adverse Events (SAEs): Incidence of SAEs - Concentrations of linvoseltamab: Concentrations of linvoseltamab in serum over time - Incidence antidrug antibodies (ADAs): Incidence of ADAs to linvoseltamab - Titer of ADA: Titer of | — |
Countries
Australia, Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey
Contacts
Public ContactChikako Rosario
Parexel International Inc.
Outcome results
None listed