Revlimid And Prednisone Followed By Revlimid, Melphalan And Prednisone In Multiple Myeloma Patients (RP_MPR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Fondazione Neoplasie Sangue Onlus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Fondazione Neoplasie Sangue Onlus
ClinicalTrials.gov Identifier:
NCT01160107
First received: July 9, 2010
Last updated: February 27, 2013
Last verified: April 2011
  Purpose

This study will determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM patients.


Condition Intervention Phase
Multiple Myeloma
Drug: RP followed by MPR
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label Study Of Oral Revlimid And Prednisone (Rp) Followed By Oral Revlimid Melphalan And Prednisone (Mpr) In Newly Diagnosed Elderly Multiple Myeloma Patients

Resource links provided by NLM:


Further study details as provided by Fondazione Neoplasie Sangue Onlus:

Primary Outcome Measures:
  • RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR) [ Time Frame: Approximately 24 months ] [ Designated as safety issue: Yes ]
    Determine whether the association of RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR) in elderly patients with newly diagnosed multiple myeloma.


Secondary Outcome Measures:
  • Determine the progression free survival (PFS), overall survival (OS) and whether responses obtained with RP - MPR treatment, are associated with a prolongation of PFS, in comparison with non-responding patients. [ Time Frame: Approximately 24 months ] [ Designated as safety issue: Yes ]

    The secondary objectives of this study are:

    • To determine progression free survival (PFS)
    • To determine overall survival (OS)
    • To determine whether responses obtained with RP - MPR treatment, are associated with a prolongation of PFS, in comparison with non-responding patients.


Enrollment: 46
Study Start Date: July 2008
Estimated Study Completion Date: August 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: RP followed by MPR
    Induction (4 cycles):Lenalidomide 25 mg/die for 21 days followed by a 7 days rest period and Prednisone at 50 mg three times a week continuously . Consolidation (6 cycles): Melphalan 2 mg three times a week, Prednisone 50 mg three times a week, and Lenalidomide 15 mg/die for 21 days followed by a 7 days rest period. According to the results of the first stage the decisions are as follows: 1. Starting a second stage, at the same dose of lenalidomide for MPR cycles, if grade 3-4 adverse events are 25-50% and PR > 50%; 2. The study stop (if PR <40% and grade 3-4 adverse events >25-30%) 3. A new first stage may be started: - Lenalidomide 20 mg/die if grade 3-4 adverse events are < 25-30%, independently from efficacy; - Lenalidomide 10 mg/die if grade 3-4 adverse events are > 50% and PR rate > 50%. Maintenance: Lenalidomide 10 mg/day from day 1 to 21, followed by a 7-day rest period and Prednisone 25 mg three times a week.Each cycle will be repeated every 28 days, until PD.
    Other Names:
    • Revlimid
    • Prednisone
    • Melphalan
Detailed Description:

This phase II study is a multicenter, open label trial designed to determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM patients.

This study consists of 3 phases for each study subject: Pre-treatment, Treatment, long-term follow-up (LTFU).

Pre-treatment period: after providing written informed consent, patients will undergo screening for protocol eligibility as outlined in the Schedule of Study Assessments.

Treatment period: includes induction, consolidation and maintenance.

Induction regimen:Patients will start induction treatment with association of Lenalidomide and Prednisone (RP).

Consolidation regimen After the completion of the 4 RP cycles therapy will continue with the MPR association:·

According to the results after the first stage the decisions are as follows: 1. The study may continue to a second stage, at the same dose of lenalidomide of MPR cycles, if grade 3-4 adverse events are 25-50% and PR > 50%;

2. The study may be stopped (if PR < 40% and grade 3-4 adverse events > 25-30%)

3. A new first stage may be started:

  • At an increase dose of Lenalidomide administered in advanced MPR cycles if grade 3-4 adverse events are < 25-30%, independently from efficacy;
  • At a reduced dose of Lenalidomide administered in advanced MPR cycles if grade 3-4 adverse events are > 50% and PR rate > 50%

Maintenance: Within 3 months from the last MPR cycle, therapy will continue with RP as maintenance.

Each cycle will be repeated every 28 days, until PD.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is 65 years of age or older at the time of signing the informed consent.
  • 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.
  • 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.
  • Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method)(Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
  • Patient was a newly diagnosed multiple myeloma based on standard criteria
  • Patient has measurable disease, defined as follows: - Secretory myeloma: 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; - Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan).
  • Patient has a Karnofsky performance status ≥ 50%.
  • Patient has a life-expectancy >3 months.

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk.
  • 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).
  • Pregnant or lactating females
  • Known positive for HIV or active infectious hepatitis type A, B or C
  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: NCT01160107

Sponsors and Collaborators
Fondazione Neoplasie Sangue Onlus
Investigators
Principal Investigator: Antonio Palumbo, MD Divisione di Ematologia dell'Università di Torino, A.O.U. San Giovanni Battista, Torino; Italy
  More Information

No publications provided

Responsible Party: Fondazione Neoplasie Sangue Onlus
ClinicalTrials.gov Identifier: NCT01160107     History of Changes
Other Study ID Numbers: RV-MM-PI-302, 2007−007616−28
Study First Received: July 9, 2010
Last Updated: February 27, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Fondazione Neoplasie Sangue Onlus:
Diagnosis
Elderly Patients
Imids
Chemotherapy

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
Prednisone
Lenalidomide
Melphalan
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 18, 2014