Study on Melphalan With or Without Siltuximab for Multiple Myeloma Patients Undergoing Stem Cell Transplant

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06679829

Provider View

This clinical trial is exploring whether adding the drug siltuximab to the usual melphalan treatment can improve outcomes for people with multiple myeloma who are receiving a stem cell transplant. The study will also assess if siltuximab helps reduce symptoms after the transplant and evaluate its safety.

Patient Parameters

Program Overview

The aim of this study is to determine if combining siltuximab with a specific dosing of melphalan is as effective as the standard melphalan treatment for people with multiple myeloma undergoing an autologous stem cell transplant. Researchers will also investigate if this combination can help alleviate symptoms post-transplant and will monitor the safety of siltuximab. Initially, 15 patients will receive siltuximab before and after their stem cell infusion.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with symptomatic multiple myeloma and planning to undergo a stem cell transplant within 12 months of diagnosis.
  • Aged 60 years or older.
  • Have enough stem cells available for the transplant.
  • Be in relatively good health, with a performance status score indicating the ability to carry out daily activities.
  • Meet specific lung and heart function criteria based on medical tests.
  • Have certain blood counts and liver and kidney function within specified limits.
  • Women must be postmenopausal or otherwise not able to become pregnant.
  • Men must agree to use birth control and not donate sperm during the study and for three months after the last dose of the study drug.

Exclusion Criteria

  • Previous treatment with drugs targeting IL-6 or its receptor.
  • Other active cancers within the past two years, except for certain skin cancers or early-stage cervical cancer.
  • Medical conditions that could interfere with the study or pose a risk to the participant.
  • Recent heart issues requiring treatment or uncontrolled heart conditions.
  • Recent vaccination with live vaccines.
  • Significant infections, including HIV or hepatitis, unless well-controlled.
  • Participation in another investigational study or recent use of investigational drugs or devices.
  • Recent hospitalization for infection or major surgery, unless fully recovered.
  • Men planning to father a child during the study or within three months after the last dose of the study drug.

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