SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

Overview

Información sobre este estudio

The purpose of this study is to demonstrate the efficacy non-inferiority between isatuximab SC and isatuximab IV in combination with pomalidomide and dexamethasone (Pd), and to demonstrate the pharmacokinetic (PK) non-inferiority between isatuximab SC and isatuximab IV in combination with Pd. 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

-Participants with multiple myeloma who have received at least one prior line of therapy
including lenalidomide and a proteasome inhibitor, and with measurable serum M-protein (≥
0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC)
assay (Involved FLC assay ≥ 10 mg/dL and abnormal serum FLC ratio (< 0.26 or > 1.65)).

Exclusion Criteria:

- Participants less than 18 years old, participants with Eastern Cooperative Oncology
Group performance status more than 2.

- Primary refractory multiple myeloma participants.

- Participants refractory to anti-CD38 with a wash-out period inferior to 9 months or
intolerant to anti-CD38 mAb agents.

- Prior therapy with pomalidomide.

- Participants with inadequate biological tests.

- Significant cardiac dysfunction.

- Participants diagnosed or treated for another cancer within 3 years prior to
randomization with the exception of complete resection of basal cell carcinoma or
squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate
cancer after curative therapy.

- Concomittant plasma cell leukemia.

- Active primary amyloid-light (AL) amyloidosis.

- Known acquired immunodeficiency syndrome (AIDS)-related illness or known human
immunodeficiency virus (HIV) disease requiring antiviral treatment.

- Hepatitis A, B, or C active infection.

- Women of childbearing potential or male participant with women of childbearing
potential who do not agree to use highly effective method of birth control.

The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.

Eligibility last updated 6/27/22. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Sikander Ailawadhi, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

Preguntas de estudios clínicos para pacientes internacionales