Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma

ConditionsRecurrent Multiple Myeloma Refractory Multiple Myeloma

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorFred Hutchinson Cancer Center

About this trial

This phase I/II trial evaluates the safety and feasibility of early, response-based dose reduction of linvoseltamab in the treatment of patients multiple myeloma that has come back after a period of improvement (relapsed), that does not respond to treatment (refractory), or that is resistant to three classes of therapeutic agents, including proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies (triple-class relapsed/refractory). Linvoseltamab is a bispecific antibody. Upon administration, linvoseltamab binds to the BCMA protein on cancer cells and the CD3 protein on T cells (a type of immune cell). This generates an immune response that stimulates the T cells to kill the cancer cells. Optimal dosing schedules of linvoseltamab have not yet been determined. Reducing the dosage of linvoseltamab may reduce treatment-related side effects while maintaining long-term disease outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years. Myeloma is not seen in the younger age group and safety of B-cell maturation antigen (BCMA) T-cell engagers (TCE) in this group is not known

Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of potential study participants

Confirmed diagnosis of active multiple myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria

Serum M protein ≥ 1 g/dl

Disqualifiers

Diagnosis of known plasma cell leukemia, known primary systemic light-chain amyloidosis (excluding myeloma-associated amyloidosis), known Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)

Patients with known MM brain lesions or meningeal involvement

History of known neurodegenerative condition, central nervous system (CNS) movement disorder, or patients with a history of seizure within 12 months prior to study enrollment

Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug

Trial design

Design model

Sequential

Treatments tested in this trial

Linvoseltamab
Biological/Vaccine
Given IV
Bone Marrow Aspiration
Procedure/Surgery
Undergo bone marrow aspiration
Bone Marrow Biopsy
Procedure/Surgery
Undergo bone marrow biopsy
Computed Tomography
Procedure/Surgery
Undergo CT or PET/CT
Positron Emission Tomography
Procedure/Surgery
Undergo PET/CT
Biospecimen Collection
Procedure/Surgery
Undergo collection of blood samples

Treatment groups

30 Participants

are divided into 4 treatment groups

Group A: Step-up dosing (linvoseltamab)Experimental treatment 6 interventions

Group B: Cohort 1 (Q4W linvoseltamab)Experimental treatment 6 interventions

Group C: Cohort 2 (Q8W linvoseltamab)Experimental treatment 6 interventions

Group D: Cohort 3 (Q12W linvoseltamab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

Number of subjects who experience early disease progression

Time frame

Within 3 months of initiation of dosing de-escalation

Secondary outcomes

Measurable residual disease (MRD) negativity

MRD negativity will be assessed at 10e\^-6.

Time frame

One year after treatment initiation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov

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