Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma

Multiple Myeloma Clinical Trial

— AMM-2011  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01617213
• Other study ID #: 16043
• Status: Terminated
• Phase: Phase 2
• First received: June 8, 2012
• Last updated: June 20, 2013
• Start date: April 2012

Study information

• Verified date: June 2013
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Melphalan
200 mg/m2/IV
• Lenalidomide
10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Free Survival	Duration of time until patient experiences an event (recurrence, relapse or death)	3 years
Secondary	Disease Response	Number of patients that have complete and very good partial responses.	2 years
Secondary	Overall survival	Duration of time from Day 0 until death.	4 years
Secondary	Grade > 2 toxicities	Percent of patients experiencing one or more toxicity greater than 2.	4 years
Secondary	Incidence of infections	Percent of patients experiencing a definite or probable viral, fungal or bacterial infection.	4 years
Secondary	Treatment related Mortality	Number of patients that experience a death from causes other relapse or progression.	4 years