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Melphalan, Total Marrow Irradiation, and Autologous Stem Cell Transplantation in Treating Patients With High-Risk Multiple Myeloma

NCT03100877 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-12-13

No results posted yet for this study

Summary

This phase I/II trial studies the side effects and best dose of melphalan and total marrow irradiation and how well they work with autologous stem cell transplantation in treating patients with high-risk multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total marrow irradiation is a type of radiation therapy and a form of total body irradiation that may deliver focused radiation to the major marrow sites where cancer cells reside. Giving chemotherapy and total-body irradiation before a peripheral autologous blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Conditions

  • Plasma Cell Leukemia in Remission
  • Plasma Cell Myeloma

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo ASCT

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Filgrastim

Given SC or IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lenalidomide

Given PO

PROCEDURE

pheresis

Undergo apheresis

DRUG

Melphalan

Given IV

BIOLOGICAL

Palifermin

Given IV

RADIATION

Total Marrow Irradiation

Undergo TMI

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • George Somlo, MD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2020-05-24
Completion
2020-05-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03100877 on ClinicalTrials.gov