Multiple Myeloma Clinical Trial
Official title:
A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
| Status | Recruiting |
| Enrollment | 424 |
| Est. completion date | November 30, 2026 |
| Est. primary completion date | November 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply: - Documented diagnosis of multiple myeloma (MM) and measurable disease - Documented disease progression during or after their last antimyeloma regimen - Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen Exclusion Criteria: - Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis - Known central nervous system (CNS) involvement with myeloma - Received immunosuppressive medication within the last 14 days of initiating study treatment - Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution - 201 | Calgary | Alberta |
| Canada | Local Institution - 205 | Edmonton | Alberta |
| Canada | Local Institution - 204 | Halifax | Nova Scotia |
| Canada | Local Institution - 202 | Montreal | Quebec |
| Canada | Local Institution - 203 | Toronto | Ontario |
| Czechia | Local Institution - 802 | Brno | |
| Czechia | Local Institution - 801 | Ostrava-Poruba | |
| Czechia | Local Institution - 803 | Praha 2 | |
| Denmark | Local Institution - 902 | Odense | |
| Denmark | Local Institution - 903 | Vejle | |
| France | Local Institution - 703 | Lille cedex | |
| France | Local Institution - 705 | Marseille cedex | |
| France | Local Institution - 704 | Nantes Cedex 01 | |
| France | Local Institution - 701 | Toulouse Cedex 9 | |
| France | Local Institution - 702 | Tours cedex | |
| Germany | Local Institution - 606 | Berlin | |
| Germany | Local Institution - 604 | Freiburg | |
| Germany | Local Institution - 605 | Hamburg | |
| Germany | Universitaetsklinikum Heidelberg | Heidelberg | |
| Germany | Local Institution - 602 | Munchen | |
| Germany | Local Institution - 603 | Wuerzburg | |
| Greece | Local Institution - 301 | Athens | |
| Italy | Local Institution - 404 | Brescia | |
| Italy | Local Institution - 401 | Milan | |
| Italy | Local Institution - 403 | Reggio Emilia | |
| Italy | Local Institution - 402 | Torino | |
| Spain | Local Institution - 504 | Badalona | |
| Spain | Local Institution - 501 | Madrid | |
| Spain | Local Institution - 508 | Madrid | |
| Spain | Local Institution - 506 | Malaga | |
| Spain | Local Institution - 505 | Pamplona | |
| Spain | Local Institution - 502 | Salamanca | |
| Spain | Local Institution - 503 | Santander | |
| Spain | Local Institution - 507 | Valencia | |
| United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Dana-Farber/Mass General Brigham Cancer Care, Inc | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Local Institution - 107 | Chicago | Illinois |
| United States | Local Institution - 112 | Chicago | Illinois |
| United States | The Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
| United States | Local Institution - 119 | Denver | Colorado |
| United States | Barbara Ann Karmanos Cancer Center | Detroit | Michigan |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | The University of Texas - MD Anderson Cancer Center | Houston | Texas |
| United States | Local Institution - 114 | Nashville | Tennessee |
| United States | Local Institution - 106 | Rochester | Minnesota |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Local Institution - 104 | Tampa | Florida |
| United States | Local Institution - 110 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recommended Dose | Up to approximately 3 years | ||
| Primary | Recommended regimen as measured by dose-limiting toxicities | Up to approximately 3 years | ||
| Primary | Number of participants with Adverse Events (AEs) | From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years | ||
| Primary | Overall response rate (ORR) | Up to approximately 5 years | ||
| Secondary | Time-to-response (TTR) | Up to approximately 5 years | ||
| Secondary | Duration of response (DOR) | Up to approximately 5 years | ||
| Secondary | Complete Response (CR) rate | Up to approximately 5 years | ||
| Secondary | Very good partial response (VGPR) rate - Cohorts D and E | Up to approximately 5 years |
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