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

Primary Purpose

Multiple Myeloma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Melphalan
Lenalidomide
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Maintenance Lenalidomide After Melphalan

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2012
Last Updated
June 20, 2013
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT01617213
Brief Title
Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma
Acronym
AMM-2011
Official Title
Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Study is no longer needed as recent data have answered the primary hypotheses for this study.
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maintenance Lenalidomide After Melphalan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
200 mg/m2/IV
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.
Primary Outcome Measure Information:
Title
Event Free Survival
Description
Duration of time until patient experiences an event (recurrence, relapse or death)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Disease Response
Description
Number of patients that have complete and very good partial responses.
Time Frame
2 years
Title
Overall survival
Description
Duration of time from Day 0 until death.
Time Frame
4 years
Title
Grade > 2 toxicities
Description
Percent of patients experiencing one or more toxicity greater than 2.
Time Frame
4 years
Title
Incidence of infections
Description
Percent of patients experiencing a definite or probable viral, fungal or bacterial infection.
Time Frame
4 years
Title
Treatment related Mortality
Description
Number of patients that experience a death from causes other relapse or progression.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary J. Laughlin, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

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Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma

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