Study Comparing Melphalan Alone to a Combination Treatment (BEAM) for Patients with Multiple Myeloma Undergoing High Dose Therapy and Stem Cell Reinfusion

Sponsor: Swedish Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03570983

Provider View

This clinical trial is comparing two different treatment approaches for patients with Multiple Myeloma who are undergoing high dose therapy followed by stem cell reinfusion. The study aims to determine which treatment is more effective in controlling the disease.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of two treatment regimens for Multiple Myeloma (MM) patients undergoing high dose therapy and stem cell reinfusion. One group will receive Melphalan alone, while the other group will receive a combination of drugs known as BEAM (Carmustine, Etoposide, Cytarabine, and Melphalan). Previous studies have shown that BEAM is safe and may be effective, but it has not been directly compared to Melphalan in a controlled trial. This study aims to fill that gap and provide valuable information on which treatment is better for patients with MM.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 70 years with a new diagnosis of Multiple Myeloma (MM) who are undergoing stem cell transplantation.
  • Must have more than 10% monoclonal plasma cells in the bone marrow or a biopsy-proven plasmacytoma.
  • Must have monoclonal protein in the blood or urine, or organ dysfunction related to MM, such as high calcium levels, kidney issues, anemia, or bone problems.
  • Must have received at least two cycles of initial therapy for MM with at least a partial response.
  • Must have a good performance status (Karnofsky score above 70).
  • Must have a life expectancy not severely limited by other illnesses.
  • Must have adequate heart, lung, liver, and kidney function.
  • Must be proficient in English and able to provide informed consent.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Individuals with limited English proficiency or cognitive impairments that prevent informed consent.
  • Those with uncontrolled infections or insufficient stem cells for transplant.
  • Individuals who have had a previous autologous transplant or plan to have a tandem transplant.
  • Those unwilling to use contraception if needed.
  • Individuals with a history of seizures or another cancer with a life expectancy of less than 3 years.
  • Those with known amyloidosis or uncontrolled central nervous system myeloma.
  • Individuals with a high anesthesia risk (ASA PS of 4 or greater).

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