Melphalan With or Without Siltuximab

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

What's the purpose of the trial?

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).
Trial status

Accepting patients

Phase
Phase 2
Enrollment
215
Last Updated
2 weeks ago
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Participating Centers

There are 5 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Melphalan is a chemotherapy medication used in the treatment of different cancers.
  • Siltuximab is a monoclonal antibody that targets interleukin IL-6 which affects inflammation in the body.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

Siltuximab plus population PK-dosed melphalan

Accepting patients

Standard BSA-dosed melphalan

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