A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant
Sponsor: Memorial Sloan Kettering Cancer Center • ClinicalTrials.gov ID: NCT06679829
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The purpose of this study is to see if siltuximab plus population pharmacokinetic (PK)-dosed melphalan works as well as the usual approach (body surface area \[BSA\]-dosed melphalan) in people with multiple myeloma (MM) who are receiving an autologous stem cell transplant (ASCT) as part of their standard treatment. The researchers will also see if siltuximab in combination with population PK-dosed melphalan works to decrease symptoms after an ASCT, and will study the safety of siltuximab. For the run-in, 15 patients will receive siltuximab, 11 mg/kg, seven days before and 14 days after autologous hematopoietic stem cell infusion (+/-2 day).
Interventions
-
Siltuximab
(Drug)
11 mg/kg, will be administered seven days before and 14 days after autologous hematopoietic stem cell infusion (+/-2 day).
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Melphalan
(Drug)
Arm A: 70mg/m2 of melphalan on Day -2. Arm B: SOC BSA based melphalan dosing at 140 or 200mg/m2 per treating physician on Day -2
Eligibility criteria
Conditions
Locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center (All protocol activities) — New York, New York, United States
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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