Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma (AMM-2011)
This study has been terminated.
(Study is no longer needed as recent data have answered the primary hypotheses for this study.)
Information provided by (Responsible Party):
Mary Laughlin, MD, University of Virginia
First received: June 8, 2012
Last updated: June 20, 2013
Last verified: June 2013
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma
Primary Outcome Measures:
Secondary Outcome Measures:
- Disease Response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Number of patients that have complete and very good partial responses.
- Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Duration of time from Day 0 until death.
- Grade > 2 toxicities [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Percent of patients experiencing one or more toxicity greater than 2.
- Incidence of infections [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Percent of patients experiencing a definite or probable viral, fungal or bacterial infection.
- Treatment related Mortality [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Number of patients that experience a death from causes other relapse or progression.
| Study Start Date:
| Estimated Primary Completion Date:
||April 2015 (Final data collection date for primary outcome measure)
Experimental: Maintenance Lenalidomide After Melphalan
10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617213
|University of Virginia
|Charlottesville, Virginia, United States, 22908 |
University of Virginia
||Mary J. Laughlin, MD
||University of Virginia
No publications provided
||Mary Laughlin, MD, Professor, Director of Stem Cell Transplant Program, University of Virginia
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 8, 2012
||June 20, 2013
||United States: Institutional Review Board
Keywords provided by University of Virginia:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 12, 2013
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action