Bortezomib, Lenalidomide, and Dexamethasone in Treating Patients With Multiple Myeloma Undergoing Stem Cell Transplant

Last updated: February 23, 2015
Sponsor: University of Colorado, Denver
Overall Status: Terminated

Phase

2

Condition

Cancer/tumors

Multiple Myeloma

Red Blood Cell Disorders

Treatment

N/A

Clinical Study ID

NCT02353468
08-0816.cc
NCI-2011-03113
  • Ages > 19
  • All Genders

Study Summary

This phase II trial studies how well giving bortezomib, lenalidomide, and dexamethasone together works in treating patients with multiple myeloma undergoing stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib, lenalidomide, and dexamethasone together may kill more cancer cells.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with symptomatic active multiple myeloma who have completed autotransplantare eligible for the study; patients should be assessed for eligibility within 35 daysof the transplant and treatment should commence within 10 weeks of the transplant

  • Performance status of 0-2 based on Southwest Oncology Group (SWOG) criteria; patientswith a poor performance status (3-4) are also eligible, if complications of the bonesuch as compression fracture, hyperviscosity or infection such as pneumonia have beenadequately treated

  • No significant co-morbid medical conditions; no uncontrolled life threateninginfection

  • Unsupported platelet count > 80,000/uL

  • Absolute neutrophil count (ANC) > 1000/uL

  • Signed informed consent should be obtained from all patients in accordance withinstitutional and federal guidelines

Exclusion

Exclusion Criteria:

  • Patients with a history of recent (< 6 months) myocardial infarction, unstable angina,difficult to control congestive heart failure, uncontrolled hypertension, difficult tocontrol significant cardiac arrhythmias, or arrhythmia associated with prolonged QTinterval

  • Pregnant or nursing women; women of child-bearing potential must have a negativepregnancy documented within one week of registration; women/men of reproductivepotential may not participate unless they have agreed to use two forms of effectivecontraceptive method

  • Patients with a grade 3-4 neuropathy related to prior exposure to bortezomib,thalidomide, or other agents

  • Human immunodeficiency virus (HIV) positive patients

  • Transaminases > 2 x normal values

  • Bilirubin > 2 x normal values

  • Active uncontrolled infection

  • History of significant psychiatric illness; steroid induced psychosis

Study Design

Total Participants: 3
Study Start date:
December 01, 2009
Estimated Completion Date:
October 31, 2011

Study Description

CONSOLIDATION: Patients receive bortezomib, lenalidomide, and dexamethasone (VLD) therapy comprising bortezomib intravenously (IV) on days 1, 4, 8, and 11, lenalidomide orally (PO) once daily (QD) on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.

In between courses of VLD, patients receive Lenalidomide + Dexamethasone (LD) therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.

MAINTENANCE: Starting in the third year of therapy, patients receive lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Connect with a study center

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

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