A trial to determine the safety of CC-92480 when combined with novel compounds in people who have Multiply Myeloma that is not responsive after treatment or has returned after a period of treatment

Phase 1

• Conditions: Relapsed or Refractory Multiple Myeloma (RRMM); MedDRA version: 21.1Level: LLTClassification code 10067095Term: Multiple myeloma progressionSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-005167-51-NO
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-24
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
1.Signed written informed consent prior to any study procedure.
2.= 18 years of age the time of signing the ICF.
3.Relapsed or refractory multiple myeloma (MM) and must:
a.have documented disease progression during or after their last myeloma therapy
b. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM
4.Must have measurable disease.
5.Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
6.Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
1.Known active or history of central nervous system (CNS) involvement of MM.
2.Plasma cell leukemia; Waldenstrom’s macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
3.Impaired cardiac function or clinically significant cardiac disease.
4.Participant has previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
5.For Part 1: received prior therapy with CC-92480.
6.For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib.
7.Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
8.Received any of the following within 14 days prior to initiating study treatment:
a.Plasmapheresis
b.Major surgery
c.Radiation therapy other than local therapy for myeloma associated bone lesions
d.Use of any systemic anti-myeloma drug therapy
9.Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment.
10.COVID-19 vaccine within 14 days prior to C1D1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified