Phase 1/2 Study of Linvoseltamab (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Previously Untreated Patients with Symptomatic Multiple Myeloma (Linker-MM4 Study)
Primary:
For phase 1, the primary objective of the study is to assess the safety, tolerability, and to determine a recommended phase 2 dose regimen (RP2DR) of linvoseltamab for phase 2 of the study.
For phase 2, the primary objectives of the study are:
To assess the preliminary anti-tumor activity of linvoseltamab in participants with
NDMM who are eligible for HDT with ASCT (transplant-eligible)
To assess the preliminary anti-tumor activity of linvoseltamab in participants with
NDMM who are ineligible for ASCT (transplant-ineligible)
The secondary objectives of the study are:
For phases 1 and 2 (applicable to both cohorts [ie, transplant-eligible and transplant-ineligible]):
To evaluate the pharmacokinetic (PK) properties of linvoseltamab
To evaluate total soluble BCMA concentrations in serum at baseline and over time
To assess the immunogenicity of linvoseltamab
For phase 1:
To assess the preliminary anti-tumor activity of linvoseltamab
For phase 2 (applicable to both cohorts):
To evaluate the safety and tolerability of linvoseltamab
To evaluate the preliminary anti-tumor activity of linvoseltamab in participants who
are transplant-eligible and transplant-ineligible
Transplant-eligible cohort only:
To evaluate duration of response (DOR), PFS, and rate of minimal residual disease
(MRD) negative status after ASCT
To evaluate the impact of therapy with single-agent linvoseltamab on the ability to
collect stem cells in any participants who subsequently undergo stem cell
mobilization
To evaluate the kinetics of engraftment
To evaluate the overall PFS
Transplant-ineligible cohort only
To evaluate DOR, PFS, and rate of MRD-negative status
- Rutgers Cancer Institute of New Jersey
Key Inclusion Criteria
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
2. Confirmed diagnosis of symptomatic multiple myeloma (MM) by International Myeloma
Working Group (IMWG) diagnosis criteria
3. Measurable disease, according to the 2016 IMWG response criteria, as defined in the
protocol
4. No prior therapy for MM, with the exception of prior emergent or palliative radiation
and up to 1 month of single-agent corticosteroids, with washout periods as per the
protocol
5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal
and cardiac function as defined in the protocol
6. Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac
function to be considered transplant-eligible. The specific thresholds for adequate
organ function are as per institutional guidance.
Key Exclusion Criteria
1. Receiving any concurrent investigational agent with known or suspected activity
against MM, or agents targeting the A proliferation-inducing ligand (APRIL)/
Transmembrane activator and calcium modulator and cyclophilin ligand interactor
(TACI)/BCMA axis
2. Known central nervous system (CNS) involvement with MM, known or suspected progressive
multifocal leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS
movement disorder, or history of seizure within 12 months prior to study enrollment
3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or
hypercalcemia not responsive to standard medical interventions), in urgent need of
treatment with chemotherapy
4. Diagnosis of non-secretory MM, active plasma cell leukemia, primary light-chain (AL)
amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, and skin changes)
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.