A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM). All eligible subjects must be previously treated with at least 3 prior regimens including lenalidomide, pomalidomide, a proteasome inhibitor and an anti-CD38 antibody and be refractory to their last line of therapy.

Key facts

Study ID

NCT03374085

Run by

Celgene

People needed

200

Starts

2018-02-06

Expected to finish

2025-10-23

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
• Subjects must have a documented diagnosis of MM and measurable disease at enrollment. Measurable disease is defined as:
• M-protein quantities ≥ 0.5 g/dL by sPEP or
• ≥ 200 mg/24 hour urine collection by uPEP or
• Serum FLC levels > 100 mg/L (milligrams/liter) involved light chain and an abnormal kappa/lambda (κ/λ) ratio in subjects without measurable serum or urine M-protein or
• For subjects with immunoglobulin class A (IgA), myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥ 0.50 g/dL.
• All subjects must have:
• Received at least 3 prior anti-myeloma regimens including at least 2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid and a CD38 antibody (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen).
• Documented disease progression on or within 60 days from the last dose of their last myeloma therapy
• Subjects who had CAR-T therapy as their last myeloma therapy are eligible as long as they have documented disease progression following CAR-T therapy.
• In addition to criteria above (a and b), subjects enrolled in Part 2 must have disease refractory to an immunomodulatory agent (lenalidomide and/or pomalidomide), a glucocorticoid, a proteasome inhibitor, and a CD38 antibody. Refractory is defined as disease that is nonresponsive on therapy (failure to achieve minimal response or development of progressive disease), or progresses within 60 days of last dose.
• Subjects must have the following laboratory values:
• Absolute neutrophil count (ANC) ≥ 1.25 x 109/L without growth factor support for ≥ 7 days (≥ 14 days for pegfilgrastim). ANC of ≥ 1.00 x 109/L is permitted for the dose expansion cohorts (Part 2).
• Hemoglobin (Hgb) ≥ 8 g/dL.
• Platelets (plt) ≥ 75 x 109/L without transfusion for ≥ 7 days.
• Corrected serum calcium ≤ 13.5 mg/dL (≤ 3.4 mmol/L).
• Creatinine clearance (CrCl) based on Cockcroft-Gault formula ≥ 45 mL/min.
• AST/SGOT and ALT/SGPT ≤ 3.0 x upper limit of normal (ULN).
• Serum bilirubin ≤ 1.5 x ULN or < 3.0 mg/dL for subjects with documented Gilbert's syndrome.
• Uric acid ≤ 7.5 mg/dL (446 µmol/L).
• PT/INR < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation).
• Females of childbearing potential (FCBP) must:

You may not qualify if…

• Subject has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Subject has any condition that confounds the ability to interpret data from the study.
• Subject has non-secretory multiple myeloma.
• Subject has refractory primary multiple myeloma (ie, no history of at least a minor response to a prior treatment regimen).
• Subject has plasma cell leukemia or active leptomeningeal myelomatosis.
• Subject has documented, systemic light chain amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome.
• Subject has immunoglobulin class M (IgM) myeloma.
• Part 1: Subject has a history of allogeneic bone marrow transplantation. Part 2: Subject has a history of allogeneic bone marrow transplantation within 6 months prior to first dose. Subject should not have ongoing graft-versus-host disease (GVHD) requiring systemic immunosuppression.
• Subject is undergoing dialysis.
• Subjects with peripheral neuropathy ≥ Grade 2.
• Subjects with gastrointestinal disease that may significantly alter the absorption of CC-92480.
• Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following:
• LVEF < 45% as determined by ECHO or MUGA scan at Screening.
• Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiographic (ECG) finding at Screening.
• A prolongation of QT interval on Screening ECG as defined by repeated demonstration of a QTc interval >480 milliseconds (ms) using Fridericia's QT correction formula; a history of or current risk factors for Torsades de Pointe (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome); and concurrent administration of medications that prolong the QT/QTc interval.
• Congestive heart failure (New York Heart Association Class III or IV).
• Myocardial infarction ≤6 months prior to starting CC-92480.
• Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris.
• Concurrent administration of strong CYP3A modulators; concurrent administration of proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole) ≤ 2 weeks prior to starting CC-92480.
• Subject had prior systemic myeloma treatment with an investigational anti-myeloma agent (eg, anti-PD-1, anti-PD-L1) ≤ 5 half-lives prior to starting CC-92480 (not applicable for subjects who had CAR-T as last prior regimen); subject had prior exposure to approved myeloma therapies (including therapeutic monoclonal antibodies such as anti-CD38 or anti-SLAMF7) ≤ 5 half-lives or within 4 weeks prior to starting CC-92480 whichever is shorter.
• Subject had major surgery ≤ 2 weeks prior to starting CC-92480. Note: Subjects must have recovered from any clinically significant effects of recent surgery.
• Subject is a pregnant or nursing female, or intends to become pregnant or donate ova during participation in the study.
• Subject has known human immunodeficiency virus (HIV) infection.
• Subject has known active chronic hepatitis B or C virus (HBV/HCV) infection.

Where it is running

• Local Institution - 102 — Atlanta, Georgia, United States
• Local Institution - 105 — Boston, Massachusetts, United States
• Local Institution - 111 — Buffalo, New York, United States
• Local Institution - 104 — New York, New York, United States
• Local Institution - 108 — Spartanburg, South Carolina, United States
• Local Institution - 101 — Nashville, Tennessee, United States
• Local Institution - 106 — Houston, Texas, United States
• Local Institution - 112 — Charlottesville, Virginia, United States
• Local Institution - 109 — Seattle, Washington, United States
• Local Institution - 804 — Camperdown, New South Wales, Australia
• Local Institution - 802 — Adelaide, South Australia, Australia
• Local Institution - 805 — Clayton, Victoria, Australia
• Local Institution - 803 — Melbourne, Victoria, Australia
• Local Institution - 806 — Fitzroy, Australia
• Local Institution - 904 — Antwerp, Belgium
• Local Institution - 905 — Ghent, Belgium
• Local Institution - 901 — Leuven, Belgium
• Local Institution - 902 — Yvoir, Belgium
• Local Institution - 201 — Calgary, Alberta, Canada
• Local Institution - 204 — London, Ontario, Canada
• Local Institution - 205 — Ottawa, Ontario, Canada
• Local Institution - 202 — Toronto, Ontario, Canada
• Local Institution - 206 — Montreal, Quebec, Canada
• Local Institution - 203 — Québec, Quebec, Canada
• Local Institution - 103 — Duarte, California, United States

Full record on ClinicalTrials.gov

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