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Combination Chemotherapy and Donor Stem Cell Transplant Followed by Ixazomib Citrate Maintenance Therapy in Treating Patients With Relapsed High-Risk Multiple Myeloma

NCT02504359 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-11-23

No results posted yet for this study

Summary

This phase Ib trial studies the side effects of combination chemotherapy and donor stem cell transplant followed by ixazomib citrate maintenance therapy in treating patients with multiple myeloma that has returned after a period of improvement and is likely to recur (come back), or spread. Giving chemotherapy before a donor peripheral blood 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 patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving ixazomib citrate after the transplant may improve the overall treatment outcome without causing additional toxicities.

Conditions

  • Plasma Cell Leukemia
  • Recurrent Plasma Cell Myeloma

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic peripheral blood stem cell transplantation

DRUG

Carmustine

Given BEAM chemotherapy

DRUG

Cytarabine

Given BEAM chemotherapy

DRUG

Etoposide

Given BEAM chemotherapy

DRUG

Ixazomib Citrate

Given PO

DRUG

Melphalan

Given BEAM chemotherapy

DRUG

Methotrexate

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic peripheral blood stem cell transplantation

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Tacrolimus

Given IV or PO

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Richard Maziarz, MD · OHSU Knight Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-07-20
Primary Completion
2020-09-09
Completion
2020-09-09

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 NCT02504359 on ClinicalTrials.gov