RecruitingPhase 2NCT06679829

A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant

Phase II Randomized Trial of Population PK Dosed Melphalan With Interleukin-6 Blockade With Siltuximab Vesrus BSA Based Melphalan in Patients With Multiple Myeloma Over Age 60 Undergoing Autologous Stem Cell Transplantation


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

215 participants

Start Date

Nov 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a drug called siltuximab to a standard high-dose chemotherapy drug (melphalan) before a stem cell transplant improves outcomes for people with multiple myeloma (a cancer of blood plasma cells). **You may be eligible if...** - You are at least 60 years old - You have been diagnosed with multiple myeloma and are planning to have an autologous stem cell transplant (using your own stem cells) within 12 months of diagnosis - Your heart, lungs, liver, and kidneys are functioning at an adequate level - You have enough stored stem cells to proceed with transplant **You may NOT be eligible if...** - You have previously received treatments that target the IL-6 protein - You have had another cancer in the past 2 years (some exceptions apply) - You have uncontrolled heart failure, a recent heart procedure, or a significant irregular heartbeat - You have HIV, active hepatitis B or C infections - You have participated in another experimental drug study within the past two weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSiltuximab

11 mg/kg, will be administered seven days before and 14 days after autologous hematopoietic stem cell infusion (+/-2 day).

DRUGMelphalan

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


Locations(7)

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

View Full Details on ClinicalTrials.gov

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NCT06679829


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