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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
215
11 mg/kg, will be administered seven days before and 14 days after autologous hematopoietic stem cell infusion (+/-2 day).
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
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
RECRUITINGrate of stringent complete response (sCR)
by modified IMWG based on the day 100 disease evaluation. Urine evaluation will be captured, but response without the urine (unless primary mode of measurement for that patient) will be used for the primary endpoint.
Time frame: 100 days
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