Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma (AMM-2011)

June 20, 2013 updated by: Mary Laughlin, MD, University of Virginia

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

This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maintenance Lenalidomide After Melphalan
Drug: Melphalan
200 mg/m2/IV
Drug: Lenalidomide
10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Free Survival
Time Frame: 3 years
Duration of time until patient experiences an event (recurrence, relapse or death)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Response
Time Frame: 2 years
Number of patients that have complete and very good partial responses.
2 years
Overall survival
Time Frame: 4 years
Duration of time from Day 0 until death.
4 years
Grade > 2 toxicities
Time Frame: 4 years
Percent of patients experiencing one or more toxicity greater than 2.
4 years
Incidence of infections
Time Frame: 4 years
Percent of patients experiencing a definite or probable viral, fungal or bacterial infection.
4 years
Treatment related Mortality
Time Frame: 4 years
Number of patients that experience a death from causes other relapse or progression.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Mary J. Laughlin, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

June 8, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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