This study is researching a drug called REGN17372 used with another drug called linvoseltamab (each individually called "study drug" or "study drugs" when combined) in participants with relapsed (when a tumor comes back) or refractory (when a tumor does not respond to treatment) multiple myeloma. This study is the first time REGN17372 will be given to humans. The aim of the study is to understand if REGN17372 can be given safely with linvoseltamab, and if so, what dosing regimen should be used for this treatment combination, in comparison with linvoseltamab alone. The study is looking at: * What side effects may happen from taking REGN17372 with linvoseltamab * How well REGN17372 and linvoseltamab, or linvoseltamab alone, work in treating multiple myeloma * What is the best dose of REGN17372 when given with linvoseltamab * How much study drug(s) are in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects) * If and how REGN17372 and linvoseltamab affect the overall quality of life, daily activities, symptoms and treatment side effects based on participant own feedback (Phase 2)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Administered per protocol
Administered per the protocol
Prince of Wales Hospital
Randwick, New South Wales, Australia
RECRUITINGIllawarra Cancer care centre, Wollongong Hospital
Wollongong, New South Wales, Australia
RECRUITINGOccurrence of Dose Limiting Toxicities (DLTs) from the first dose of REGN17372 in combination with linvoseltamab
Phase 1
Time frame: Up to 35 days
Occurrence of Treatment Emergent Adverse Events (TEAEs) associated with REGN17372 in combination with linvoseltamab
Phase 1
Time frame: Up to 5 years
Severity of TEAEs associated with REGN17372 in combination with linvoseltamab
Phase 1
Time frame: Up to 5 years
Very Good Partial Response (VGPR) or better as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria in patients receiving combination study drugs
Phase 2
Time frame: Within 12 weeks of starting cycle 1
VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy
Phase 2
Time frame: Within 12 weeks of starting cycle 1
Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination study drugs
Phase 2
Time frame: Within 12 weeks of starting cycle 1
PR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy
Phase 2
Time frame: Within 12 weeks of starting cycle 1
Concentrations of REGN17372 in serum
Phase 1 and Phase 2
Time frame: Up to 5 years
Concentrations of linvoseltamab in serum
Phase 1 and Phase 2
Time frame: Up to 5 years
Occurrence of Anti-Drug Antibodies (ADA) to REGN17372
Phase 1 and Phase 2
Time frame: Up to 5 years
Magnitude of ADA to REGN17372
Phase 1 and Phase 2
Time frame: Up to 5 years
Incidence of ADA to linvoseltamab
Phase 1 and Phase 2
Time frame: Up to 5 years
Magnitude of ADA to linvoseltamab
Phase 1 and Phase 2
Time frame: Up to 5 years
Objective Response Rate (ORR) as assessed by IMWG response criteria as determined by the investigator
Phase 1 and Phase 2
Time frame: Up to 5 years
Complete response (CR) as assessed by IMWG response criteria as determined by the investigator
Phase 1 and Phase 2
Time frame: Up to 5 years
VGPR as assessed by IMWG response criteria, as determined by the investigator
Phase 1 and Phase 2
Time frame: Up to 5 years
Duration of Response (DOR) as assessed by IMWG criteria as determined by the investigator
Phase 1 and Phase 2
Time frame: Up to 5 years
Progression Free Survival (PFS) as assessed by IMWG criteria as determined by the investigator
Phase 1 and Phase 2
Time frame: Up to 5 years
Minimal Residual Disease (MRD) negative status (at 10^-5) in participants in CR or better
Phase 1 and Phase 2
Time frame: Up to 5 years
Overall Survival (OS)
Phase 1 and Phase 2
Time frame: Up to 5 years
ORR as assessed using the IMWG response criteria as determined by the investigator in patients receiving combination study drugs
Phase 1
Time frame: Within 12 weeks of starting cycle 1
VGPR assessed using IMWG criteria as determined by the investigator in patients receiving combination study drugs
Phase 1
Time frame: Within 12 weeks of starting cycle 1
Incidence of TEAEs
Phase 2
Time frame: Up to 5 years
Severity of TEAEs
Phase 2
Time frame: Up to 5 years
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Global Health Status / Quality of Life (GHS/QoL)
Phase 2 The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much"
Time frame: Up to 5 years
Change from baseline in EORTC QLQ-C30 Physical Functioning (PF)
Phase 2
Time frame: Up to 5 years
Change from baseline in EORTC QLQ-C30 Role Functioning (RF)
Phase 2
Time frame: Up to 5 years
Change from baseline in EORTC QLQ-C30 pain
Phase 2
Time frame: Up to 5 years
Change from baseline in EORTC QLQ-C30 fatigue
Phase 2
Time frame: Up to 5 years
Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL
Phase 2
Time frame: Up to 5 years
Time to definitive deterioration in EORTC QLQ-C30 PF
Phase 2
Time frame: Up to 5 years
Time to definitive deterioration in EORTC QLQ-C30 RF
Phase 2
Time frame: Up to 5 years
Time to definitive deterioration in EORTC QLQ-C30 pain
Phase 2
Time frame: Up to 5 years
Time to definitive deterioration in EORTC QLQ-C30 fatigue
Phase 2
Time frame: Up to 5 years
Time to first improvement in EORTC QLQ-C30 GHS/QoL
Phase2
Time frame: Up to 5 years
Time to first improvement in EORTC QLQ-C30 PF
Phase 2
Time frame: Up to 5 years
Time to first improvement in EORTC QLQ-C30 RF
Phase 2
Time frame: Up to 5 years
Time to first improvement in EORTC QLQ-C30 pain
Phase 2
Time frame: Up to 5 years
Time to first improvement in EORTC QLQ-C30 fatigue
Phase 2
Time frame: Up to 5 years
Change from baseline in EORTC QLQ-Multiple Myeloma Module (MY20) Disease Symptoms (DS)
Phase 2 The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems
Time frame: Up to 5 years
Time to definitive deterioration in EORTC QLQ-MY20 DS
Phase 2
Time frame: Up to 5 years
Time to first improvement in EORTC QLQ-MY20 DS
Phase 2
Time frame: Up to 5 years
Change from baseline in EORTC QLQ-MY20 Treatment Side Effects (TSE)
Phase 2
Time frame: Up to 5 years
Time to definitive deterioration in EORTC QLQ-MY20 TSE
Phase 2
Time frame: Up to 5 years
Time to first improvement in EORTC QLQ-MY20 TSE
Phase 2
Time frame: Up to 5 years
Change from baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS)
Phase 2 The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems
Time frame: Up to 5 years
Time to definitive deterioration in EQ-5D-5L VAS
Phase 2
Time frame: Up to 5 years
Time to first improvement in EQ-5D-5L VAS
Phase 2
Time frame: Up to 5 years
Patient-reported overall impact of treatment toxicity measured by Functional Assessment of Cancer Therapy (FACIT) Item GP5
Phase 2 The FACIT Item GP5 will be used to assess the patient-reported impact of treatment toxicity that uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much)
Time frame: Up to 5 years
Patient-reported tolerability as measured by the Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Phase 2 The PRO-CTAE questionnaire assesses side effects and symptoms in cancer clinical trials using a PRO-CTCAE score. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic AEs drawn from the CTCAE
Time frame: Up to 5 years
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