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Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma


Phase 2
18 Years
75 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma


Inclusion Criteria:



- Must be 18 to 75 years of age.

- ECOG performance status of 0, 1 or 2.

- Patients who have a history of another malignant disorder are eligible, provided that
they have not received active therapy for 5 years. Patients with basal cell and
squamous cell skin cancers are eligible.

- Patients who are pregnant are ineligible.

- Patients must furnish written informed consent and HIPAA authorization for release of
personal health information.

- Patients must be able to understand the requirements of the study, abide by the study
restrictions, and agree to return for the required assessments.

- Patients must be HIV and HTLV-I,-II antibody sero-negative.

- Patients must have adequate visceral organ function

Exclusion Criteria:

- Patients are ineligible if they have received cumulative chemotherapy doses in excess
of: carmustine (BCNU) 400 mg/m2, or a cumulative anthracycline exposure in excess of
550 mg/m2 Adriamycin (doxorubicin) unless the gated-pool radionuclide cardiac scan
shows greater than/equal to 45% ejection fraction.

- Patients are ineligible if they are receiving any other investigational agents.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event Free Survival

Outcome Description:

Duration of time until patient experiences an event (recurrence, relapse or death)

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Mary J. Laughlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Institutional Review Board

Study ID:

16043

NCT ID:

NCT01617213

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of VirginiaCharlottesville, Virginia  22908