Titre complet:

A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of ABBV-383 in Subjects With Relapsed or Refractory Multiple Myeloma

Stade ou Condition:

Multiple Myeloma

Phase d'étude:

Phase 1

Résumé:

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study 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 is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A 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 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the world. Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Description détaillée:

Non disponible

Traitements:

Drug : ABBV-383

Intravenous Infusion

Groupes d'étude:

Experimental : Arm A (Part 1): ABBV-383 Dose Escalation
B-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.

Experimental : Arm A (Part 2): ABBV-383 Dose Expansion
BCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.

Experimental : Arm B: ABBV-383 Dose Expansion
Participants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.

Type d'étude:

Interventional

Protocole de l'étude:

Allocation: Non-Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Statut du recrutement:

En cours

Critères d'admissibilités:

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.

Lieux / Centres:

Juravinski Cancer Centre /ID# 252053, Hamilton, Ontario – En cours

Ottawa Hospital Research Institute /ID# 252151, Ottawa, Ontario – En cours

Contacts:

Name: ABBVIE CALL CENTER
Phone: 844-663-3742
Email: [email protected]

Publications:

???

Date d’affichage:

2022-12-14

Date de début:

March 21, 2023

Dernière mise à jour:

2024-02-02

Nombre d'inscriptions anticipées:

120

Date de fin prévue:

2026-07-12

Date de fin prévue de l'étude primaire:

2026-07-12

Condition:

Multiple Myeloma

Genre:

All

Âge:

18 Years-N/A

Accepte des bénévoles en santé:

No

Pays participants:

Canada

Denmark

France

Israel

Spain

United Kingdom

United States

Numéro d’identification:

NCT05650632

Autres numéros d'identification de l'étude:

M24-108

Comité de suivi des données:

No

Produit réglementé par la FDA (É-U):

Yes

IPD Sharing Statement :

???

Responsables de l’étude:

Sponsor

Commanditaires de l’étude:

lead_sponsor
TeneoOne Inc.
Industry

Collaborators:

???

Chercheurs:

TeneoOne Inc TeneoOne Inc.

Protocol Registration and Results System:

???

Date de vérification:

2024-02-01