Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma (AMM-2011)
This study is currently recruiting participants.
Verified June 2012 by University of Virginia
Sponsor:
University of Virginia
Information provided by (Responsible Party):
Mary Laughlin, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01617213
First received: June 8, 2012
Last updated: June 11, 2012
Last verified: June 2012
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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.
| Estimated Enrollment: | 66 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617213
Contacts
| Contact: Hannah Spencer, MSc | 434-243-5811 | hes3x@virginia.edu |
| Contact: Amy Camblos, BS | 434-982-3948 | akc4c@virginia.edu |
Locations
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Amy K Camblos, BS 434-982-3948 akc4c@virginia.edu | |
| Principal Investigator: Mary J Laughlin, MD | |
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 11, 2012 |
| 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 Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013