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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01617213
Recruitment Status : Terminated (Study is no longer needed as recent data have answered the primary hypotheses for this study.)
First Posted : June 12, 2012
Last Update Posted : June 21, 2013
Information provided by (Responsible Party):
Mary Laughlin, MD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Melphalan Drug: Lenalidomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma
Study Start Date : April 2012
Estimated Primary Completion Date : April 2015

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Event Free Survival [ Time Frame: 3 years ]
    Duration of time until patient experiences an event (recurrence, relapse or death)

Secondary Outcome Measures :
  1. Disease Response [ Time Frame: 2 years ]
    Number of patients that have complete and very good partial responses.

  2. Overall survival [ Time Frame: 4 years ]
    Duration of time from Day 0 until death.

  3. Grade > 2 toxicities [ Time Frame: 4 years ]
    Percent of patients experiencing one or more toxicity greater than 2.

  4. Incidence of infections [ Time Frame: 4 years ]
    Percent of patients experiencing a definite or probable viral, fungal or bacterial infection.

  5. Treatment related Mortality [ Time Frame: 4 years ]
    Number of patients that experience a death from causes other relapse or progression.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01617213

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

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Responsible Party: Mary Laughlin, MD, Professor, Director of Stem Cell Transplant Program, University of Virginia Identifier: NCT01617213    
Other Study ID Numbers: 16043
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by Mary Laughlin, MD, University of Virginia:
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents