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Allogeneic Stem Cell Transplantation for Multiple Myeloma and Myelofibrosis

NCT03303950 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-05-05

Study results available
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Summary

This phase II trial studies how well busulfan, fludarabine, donor stem cell transplant, and cyclophosphamide in treating participants with multiple myeloma or myelofibrosis. Drugs used in chemotherapy, such as busulfan, fludarabine, and cyclophosphamide, 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. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving busulfan and fludarabine before and cyclophosphamide after donor stem cell may work better in treating participants with multiple myeloma or myelofibrosis.

Conditions

  • Anemia
  • ASXL1 Gene Mutation
  • EZH2 Gene Mutation
  • IDH1 Gene Mutation
  • IDH2 Gene Mutation
  • Plasma Cell Myeloma
  • Primary Myelofibrosis
  • Recurrent Plasma Cell Myeloma
  • Secondary Myelofibrosis
  • Thrombocytopenia

Interventions

DRUG

Busulfan

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

PROCEDURE

Hematopoietic Cell Transplantation

Undergo HSCT

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Catherine Lee, MD · Huntsman Cancer Institute/ University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-03-30
Primary Completion
2019-05-14
Completion
2020-02-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03303950 on ClinicalTrials.gov