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.)
Sponsor:
Information provided by (Responsible Party):
Mary Laughlin, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01617213
First received: June 8, 2012
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Melphalan
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Event Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Duration of time until patient experiences an event (recurrence, relapse or death)


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.


Enrollment: 1
Study Start Date: April 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617213

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Mary J. Laughlin, MD University of Virginia
  More Information

No publications provided

Responsible Party: Mary Laughlin, MD, Professor, Director of Stem Cell Transplant Program, University of Virginia
ClinicalTrials.gov Identifier: NCT01617213     History of Changes
Other Study ID Numbers: 16043
Study First Received: June 8, 2012
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Lenalidomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014