Study on Different Treatment Sequences for Newly Diagnosed Standard-Risk Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT06577025
This clinical trial is exploring different sequences of treatments for patients with newly diagnosed standard-risk multiple myeloma. The study aims to evaluate how well these treatments work over time, particularly looking for signs of potential cure after five years.
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Program Overview
The goal of this study is to see how effective different sequences of treatments are for patients with newly diagnosed standard-risk multiple myeloma. Researchers are looking for signs of potential cure, defined as no detectable cancer cells and clear PET/CT scans after five years. They will also measure how long patients live without the disease getting worse, known as progression-free survival (PFS).
Eligibility Criteria
Inclusion Criteria
- Have a new diagnosis of multiple myeloma (MM) based on international criteria.
- Have standard-risk MM, classified as stage I or II.
- Be considered fit or intermediate-fit according to a specific health assessment.
- Have measurable disease, which means certain levels of proteins in the blood or urine.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
Exclusion Criteria
- Have any ongoing blood disorders or cancers other than MM that require treatment.
- Have nerve damage or pain rated as Grade 2 or higher.
- Have a history of brain or spinal cord involvement by MM.
- Have had a stroke or seizure in the past six months.
- Have plasma cell leukemia or other specific blood disorders.
- Have high-risk disease features, such as certain genetic markers or tumors outside the bone marrow.
- Test positive for HIV.
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