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Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant

NCT01706666 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-09-17

Study results available
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Summary

This randomized phase II trial studies how well giving bortezomib with or without combination chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bortezomib is more effective with or without combination chemotherapy in the post transplant setting.

Conditions

  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma

Interventions

DRUG

bortezomib

Given SC

DRUG

cyclophosphamide

Given PO

DRUG

lenalidomide

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

DRUG

dexamethasone

Given PO

PROCEDURE

quality-of-life assessment

Ancillary studies

Sponsors & Collaborators

Principal Investigators

  • Craig B. Reeder, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-07
Primary Completion
2014-07-10
Completion
2016-05-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01706666 on ClinicalTrials.gov