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Lenalidomide Melphalan and Prednisone Versus High Dose Melphalan in Newly Diagnosed Multiple Myeloma Patients (MPRvsMEL200)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Fondazione Neoplasie Sangue Onlus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fondazione Neoplasie Sangue Onlus
ClinicalTrials.gov Identifier:
NCT00551928
First received: October 30, 2007
Last updated: March 16, 2010
Last verified: March 2010
  Purpose

To compare the efficacy of the combination of lenalidomide with low-dose melphalan versus high-dose melphalan in newly diagnosed, symptomatic MM patients.


Condition Intervention Phase
Multiple Myeloma
Newly Diagnosed Patients
Drug: Melphalan
Drug: Lenalidomide
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF LENALIDOMIDE, MELPHALAN AND PREDNISONE (MPR) Versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CELL TRANSPLANT IN NEWLY DIAGNOSED MULTIPLE MYELOMA SUBJECTS

Resource links provided by NLM:


Further study details as provided by Fondazione Neoplasie Sangue Onlus:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Over all survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 402
Study Start Date: June 2007
Estimated Study Completion Date: August 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Oral therapy with Lenalidomide Melphalan and Prednisone.
Drug: Lenalidomide
Six months of oral therapy with Lenalidomide 10mg/day given 21 days in every 28 days cycle with the combination ofMelphalan and steroids (day 22 to 28), for 6 cycles every 28 days.
Drug: Prednisone
Given orally at the dose of 2 mg/Kg for 4 days followed by a 24 day rest period (days 5 to 28), for 6 cycles every 28 days
Drug: Melphalan
Melphalan will be given orally at the dose of 0.18 mg/Kg for 4 days, followed by a 24 days rest period (day 5 to 28)for 6 cycles every 28 days
Active Comparator: B
High dose Melphalan therapy (200mg/sm)with autologous stem cell support, for 2 cycles every 4 months (only 1 cycle if the patient reached almost a VGPR after the 1st MEL200)
Drug: Melphalan
High dose Melphalan 200mg/sm with autologous stem cell support

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
  • Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  • Patient is 65 years old or younger at the time of signing the informed consent
  • Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable double method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Negative serum β-human chorionic gonadotropin ( β-HCG) pregnancy test both 24 hours prior to beginning of therapy and then at 4 weeks intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles during study treatment for subjects of childbearing potential
  • Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
  • Patient was diagnosed with symptomatic multiple myeloma based on standard criteria (9), and has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours; measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan); bone marrow plasma cells>10%.
  • Patient has a Karnofsky performance status ≥ 60%.
  • Patient has a life-expectancy > 6 months
  • Patient has not active infectious hepatitis type B or C, and has HIV negative test
  • Patients must have an ejection fraction by ECHO or MUGA > 50% performed within 60 days prior to registration
  • Patients must have adequate pulmonary function studies > 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > 50% of predicted. Patients unable to complete pulmonary function tests because of myeloma-related chest pain, must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70.
  • Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1):

    • Platelet count ≥ 75 x 109/L without transfusion support within 7 days before the test.
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without the use of growth factors.
    • Corrected serum calcium ≤ 14 mg/dL (3.5 mmol/L).
    • Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN).
    • Alanine transaminase (ALT): ≤ 2.5 x the ULN.
    • Total bilirubin: ≤ 1.5 x the ULN.
    • Calculated or measured creatinine clearance: ≥ 30 mL/minute
  • Patient has a baseline bone marrow sample available for cytogenetics, that will be processed and eventually centralized within each country.

Exclusion Criteria:

  • Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; < to the equivalent of dexamethasone 40 mg/day for 4 days).
  • Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
  • Pregnant or lactating females.
  • Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
  • Neuropathy of ≥ grade 2 severity.
  • Patients previously diagnosed as bearing deep venous thrombosis or arterial thromboembolic event within the latest 12 months, or bearing a clear indication for anti-platelet or anticoagulant therapy or bearing a high risk of bleeding complications are ineligible for the sub-study protocol.
  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: NCT00551928

Locations
Italy
Division of Hematology, Molinette Hospial
Torino, Italy, 10126
Sponsors and Collaborators
Fondazione Neoplasie Sangue Onlus
Investigators
Principal Investigator: Antonio Palumbo, MD FONESA Onlus
  More Information

No publications provided by Fondazione Neoplasie Sangue Onlus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Mario Boccadoro, FO.NE.SA. Onlus
ClinicalTrials.gov Identifier: NCT00551928     History of Changes
Other Study ID Numbers: RV-MM-PI-209
Study First Received: October 30, 2007
Last Updated: March 16, 2010
Health Authority: Italy: Ethics Committee and Ministry of Health
Israel: Ethics Commission and Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Fondazione Neoplasie Sangue Onlus:
Multiple Myeloma
Lenalidomide
High dose Melphalan
Mobilization
CD34

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Lenalidomide
Melphalan
Prednisone
Thalidomide
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Glucocorticoids
Growth Inhibitors
Growth Substances

ClinicalTrials.gov processed this record on November 25, 2014