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)
| Verified date | May 2024 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
| Status | Active, not 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 - 604 | Freiburg | |
| Germany | Local Institution - 605 | Hamburg | |
| Germany | Local Institution - 601 | 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 | Local Institution - 108 | Atlanta | Georgia |
| United States | Local Institution - 101 | Boston | Massachusetts |
| United States | Local Institution - 117 | Boston | Massachusetts |
| United States | Local Institution - 118 | Boston | Massachusetts |
| United States | Local Institution - 107 | Chicago | Illinois |
| United States | Local Institution - 112 | Chicago | Illinois |
| United States | Local Institution - 115 | Columbus | Ohio |
| United States | Local Institution - 119 | Denver | Colorado |
| United States | Local Institution - 113 | Detroit | Michigan |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Local Institution - 116 | 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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