This study is currently not recruiting participants.

Phase I/II Study of Oral Lenalidomide and High Dose Melphalan Supported by Autologous Peripheral Blood Stem Cell Infusion for Patients With Multiple Myeloma

Investigating the Effects of Lenalidomide and Melphalan on Multiple Myeloma

Not Recruiting
18 years - 100 years
All
Phase N/A

Brief description of study.

The purpose of this study is to find the highest dose of a drug called lenalidomide (Revlimid?) that can be given in combination with high dose melphalan without causing severe adverse events and to find out the effects of this treatment (good and bad) on multiple myeloma patients.

Detailed description of study

Lenalidomide is a drug that interferes with the development of tiny blood vessels that help tumors grow. Lenalidomide in combination with dexamethasone is approved by the Food and Drug Administration (FDA) for the treatment of relapsed multiple myeloma. It is also approved for the treatment of specific types of myelodysplastic syndrome (MDS), another blood cancer. Other research studies using lenalidomide in combination with other drugs in subjects with newly diagnosed multiple myeloma also show good response rate. High dose melphalan is approved by the FDA and is commonly used in multiple myeloma treatment prior to stem cell transplantation. This combination of lenalidomide, high-dose melphalan and stem cell transplantation has not been studied in newly diagnosed and relapsed multiple myeloma, so it is considered experimental. In research studies, "experimental" refers to a drug or procedure that has undergone basic laboratory testing and received approval from the US Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered experimental in other diseases or conditions. In this study, lenalidomide will be given together with melphalan (chemotherapy) with the hope that more disease will be killed before the stem cell transplant. Three months after the transplant, patients will take lenalidomide again with the hope that this will help prolong the time when the disease is in remission.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Myeloma
  • Age: 18 years - 100 years
  • Gender: All

This study investigates the effects of an investigational treatment on patients with multiple myeloma, a type of blood cancer. The purpose is to determine the highest dose of an investigational medication that can be safely given with high dose chemotherapy. Multiple myeloma affects plasma cells in the bone marrow, and this study aims to explore how this combination treatment impacts the disease.

Participants in this study will receive a combination of investigational medication and chemotherapy. The investigational medication is thought to interfere with blood vessel growth that supports tumors. After a stem cell transplant, participants will continue to receive the investigational medication to see if it can keep the disease in remission for a longer period.

  • Who can participate: Participants must have a diagnosis of multiple myeloma and meet specific age and health criteria.
  • Study details: Participants will receive lenalidomide and melphalan combined with chemotherapy before a stem cell transplant. High dose melphalan is used to enhance the chemotherapy's effectiveness. After the transplant, they will take lenalidomide again. A placebo is not involved in this study.
Updated on 19 Feb 2024. Study ID: 1105005516

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