| Titre |
A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-92328 in Subjects With Relapsed and/or Refractory Multiple Myeloma |
| Protocole ID |
CC-92328-MM-001 |
| ClinicalTrials.gov ID |
NCT04975399 |
| Type(s) de cancer |
Myélome |
| Phase |
Phase I |
| Stade |
Récidivant/réfractaire (2ième ligne de traitement et plus) |
| Type étude |
Clinique |
| Médicament |
CC-92328 |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Chaim Shustik
Dr Michael Sebag
|
| Coordonnateur(trice) |
Nancy Renouf
514-934-1934 poste 35718
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
Participants must satisfy the following criteria to be enrolled in the study:
- must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
- willing and able to adhere to the study visit schedule and other protocol requirements.
- Participant is ≥ 18 years of age the time of signing the ICF.
- Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease who have failed or who are ineligible or intolerant to available therapies that may provide clinical benefit.
- Have documented disease progression on or within 12 months from the last dose of their last myeloma therapy.
- Participant must have measurable disease.
- Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Females of childbearing potential (FCBP) must commit to true abstinence from heterosexual contact or agree to use at least one method of highly effective contraception without interruption from screening to at least 12 weeks after the last dose of CC-92328
- Males must practice true abstinence or agree to use a condom
- FCBP and males must avoid conceiving from signing the ICF, while participating in the study, during dose interruptions, and for at least 12 weeks after the last dose of CC-92328.
|
| Critètes d'exclusion |
The presence of any of the following will exclude a participant from enrollment:
- Participant has symptomatic central nervous system involvement of MM.
- Participant had a prior autologous stem cell transplant ≤ 90 days prior to starting CC-92328.
- Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior to starting CC-92328.
- Participant had prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting CC-92328, whichever is shorter.
- Participant is a pregnant or lactating female.
- Participant received live virus vaccines within at least 4 weeks prior to starting study drug.
- Participant has known active human immunodeficiency virus (HIV) infection.
- Participant has active hepatitis B or C (HBV/HCV) infection.
- Participant weight is ≤ 40 kg at screening.
|
Groupe d'étude en oncologie du Québec