CompletedPhase 1/2

First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)

United States43 participantsStarted 2019-09-26

Plain-language summary

In the phase 1 portion of the study, the primary objectives are to assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of REGN5459 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit. In the phase 2 portion of the study, the primary objective is to assess the preliminary anti-tumor activity of REGN5459 as measured by objective response rate (ORR). In the phase 1 and phase 2 portion, the secondary objectives of the study are: * To assess the preliminary anti-tumor activity of REGN5459 as measured by duration of response (DOR), progression-free survival (PFS), rate of minimal residual disease (MRD) negative status, and overall survival (OS) * To evaluate the pharmacokinetic (PK) properties of REGN5459 * To characterize the immunogenicity of REGN5459 * To evaluate the effects of REGN5459 on patient-reported quality of life (QoL), symptoms, functioning and general health status In the phase 1 portion of the study only, the secondary objective of the study is to assess the preliminary anti-tumor activity of REGN5459 as measured by ORR. In the phase 2 portion of the study only, the secondary objective of the study is to evaluate the safety and tolerability of REGN5459.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Serum M-protein ≥1 g/dL,
✓. Urine M-protein ≥200 mg/24-hour, and/or
✓. Free light chain (FLC) assay with involved FLC level ≥10 mg/dL with an abnormal serum FLC ratio
✓. Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory imide drug (IMiD), and an anti-CD38 antibody, OR
✓. Progression on or after an anti-CD38 antibody and having disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor. Refractory disease is defined as lack of response or relapse within 60 days of last treatment.
✓. Platelet count \> 50 x 109/L. A patient may not have received a platelet transfusion within 7 days to meet this platelet eligibility requirement.
✓. ANC \> 1.0 x 109/L. A patient may not have received granulocyte colony stimulating factor (G-CSF) within 2 days to meet this absolute neutrophil count eligibility requirement.
✓. Hemoglobin \> 8.0 g/dL

Exclusion criteria

What they're measuring

Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period

Timeframe: Up to 35 Days

Incidence and severity of treatment-emergent adverse events (TEAEs) during REGN5459 treatment period

Timeframe: Up to 12 Weeks After the Last Dose

Incidence and severity of adverse events of special interest (AESI) with REGN5459 treatment period

Timeframe: Up to 12 Weeks After the Last Dose

Objective response rate (ORR) as measured using the International Myeloma Working Group (IMWG) criteria

Timeframe: Up to Approximately 104 Weeks

Trial details

NCT IDNCT04083534

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-01

View on ClinicalTrials.gov More Relapsed Multiple Myeloma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Serum M-protein ≥1 g/dL,
✓. Urine M-protein ≥200 mg/24-hour, and/or
✓. Free light chain (FLC) assay with involved FLC level ≥10 mg/dL with an abnormal serum FLC ratio
✓. Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory imide drug (IMiD), and an anti-CD38 antibody, OR
✓. Progression on or after an anti-CD38 antibody and having disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor. Refractory disease is defined as lack of response or relapse within 60 days of last treatment.
✓. Platelet count \> 50 x 109/L. A patient may not have received a platelet transfusion within 7 days to meet this platelet eligibility requirement.
✓. ANC \> 1.0 x 109/L. A patient may not have received granulocyte colony stimulating factor (G-CSF) within 2 days to meet this absolute neutrophil count eligibility requirement.
✓. Hemoglobin \> 8.0 g/dL

Exclusion criteria

What they're measuring

Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period

Timeframe: Up to 35 Days

Incidence and severity of treatment-emergent adverse events (TEAEs) during REGN5459 treatment period

Timeframe: Up to 12 Weeks After the Last Dose

Incidence and severity of adverse events of special interest (AESI) with REGN5459 treatment period

Timeframe: Up to 12 Weeks After the Last Dose

Objective response rate (ORR) as measured using the International Myeloma Working Group (IMWG) criteria

Timeframe: Up to Approximately 104 Weeks