Study Stopped
Study is no longer needed as recent data have answered the primary hypotheses for this study.
Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma
AMM-2011
Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma
1 other identifier
interventional
1
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 8, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedJune 21, 2013
June 1, 2013
3 years
June 8, 2012
June 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event Free Survival
Duration of time until patient experiences an event (recurrence, relapse or death)
3 years
Secondary Outcomes (5)
Disease Response
2 years
Overall survival
4 years
Grade > 2 toxicities
4 years
Incidence of infections
4 years
Treatment related Mortality
4 years
Study Arms (1)
Maintenance Lenalidomide After Melphalan
EXPERIMENTALInterventions
10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary J. Laughlin, MD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of Stem Cell Transplant Program
Study Record Dates
First Submitted
June 8, 2012
First Posted
June 12, 2012
Study Start
April 1, 2012
Primary Completion
April 1, 2015
Last Updated
June 21, 2013
Record last verified: 2013-06