A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma

Overview

Información sobre este estudio

The purpose of this study is to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study includes 2 parts; step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 will be used followed by the target dose of ABBV-383. 

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:

- Must have measurable disease as outlined in the protocol.

- Eastern Cooperative Oncology Group (ECOG) performance of <= 2.

- Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of
progression during or after the participant's last treatment regimen based on the
investigator's determination of the International Myeloma Working Group (IMWG) 2016
criteria.

- Must be naïve to treatment with ABBV-383.

- Arm A: Must have received at least 3 or more lines of therapy, including a proteasome
inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal
antibody.

- Arm B: Must have received at least 2 or more lines of therapy, including exposure to a
PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen
(BCMA)-targeted therapy (anti-drug conjugate [ADC] or chimeric antigen receptor T-cell
[CAR-T] directed against BCMA).

Exclusion Criteria:

- Arm A: Received BCMA-targeted therapy.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/8/24. 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

Rochester, Minn.

Investigador principal de Mayo Clinic

Shaji Kumar, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Saurabh Chhabra, M.B.B.S.

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)

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