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Treatment With a Scheme With Low Doses of Bortezomib / Melphalan / Prednisone (MPV) in Patients With Multiple Myeloma (Velcadito)

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ClinicalTrials.gov Identifier: NCT02773550
Recruitment Status : Unknown
Verified May 2016 by Ernesto Perez Persona, Basque Health Service.
Recruitment status was:  Recruiting
First Posted : May 16, 2016
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Ernesto Perez Persona, Basque Health Service

Brief Summary:

This clinical trial is a multicenter, cohort, with one arm to study the SLP to 18 months of Velcadito scheme (velcade 1.0 mg / m2 administered over two days with melphalan and prednisone) in patients with MM diagnosis again higher 75. After completion of the protocol patients were still approximately every two months, in clinical practice, to observe the survival and answers to other treatments. All the scans are part of the normal routine. The realization of diagnostic tests and drug treatment will be performed regardless of the patient's participation in the study as part of routine clinical practice All patients who meet criteria. The incidence of MM age-adjusted to cover the participating hospitals is estimated in 44 patients.

Patients will receive a course of 4 weeks duration of Melphalan / Prednisone / Velcade consist in Melphalan, 9 mg / m2 orally daily 1-4 and Prednisone 60 mg / m2 orally on days 1 to 4, in combination Velcade with a dose of 1.3 mg / m2 sc twice weekly (days 1, 4, 8, 11), followed by 2 weeks of rest (cycle duration of 4 weeks) and seven four-week cycles duration of melphalan / prednisone / Velcade consist in Melphalan, 9 mg / m2 orally on days 1 to 4 and prednisone, 60 mg / m2 orally on days 1 to 4, in combination with Velcade, at doses of 1, 0 mg / m2 sc (days 1, 4).

Melphalan and Prednisone will be dispensed for oral administration. The Melphalan should be administered in a single two hours separately taking any food and prednisone be taken in the morning with or immediately after a meal. The amount in mg will be calculated based on the body surface, to be calculated on day 1 of each cycle. Velcade for administration, calculated on day 1 of the cycle will be the same dose throughout the entire cycle. If a patient experiences a gain or loss of remarkable weight within the cycle, the dose to be administered will be recalculated based on the new body surface. The appropriate amount of Velcadeserá dispensed in a sc injection. Velcade dose between two leave at least 72 hours


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bortezomib Drug: Melphalan Drug: Prednisone Phase 4

Detailed Description:

This clinical trial is a multicenter, cohort, with one arm to study the SLP to 18 months of Velcadito scheme (velcade 1.0 mg / m2 administered over two days with melphalan and prednisone) in patients with MM diagnosis again higher 75. After completion of the protocol patients were still approximately every two months, in clinical practice, to observe the survival and answers to other treatments. All the scans are part of the normal routine. The realization of diagnostic tests and drug treatment will be performed regardless of the patient's participation in the study as part of routine clinical practice All patients who meet criteria. The incidence of MM age-adjusted to cover the participating hospitals is estimated in 44 patients.

Clinical Study Materials:

  • Melphalan is presented for oral administration of 2 mg tablets.
  • Prednisone is presented for oral administration in tablets 50, 30, 10, 5 and 2.5 mg to set the correct dose to be administered.
  • Velcade.- (Bortezomib) for subcutaneous administration. All study drugs will be administered to patients under the prescription of the investigator or sub-investigators identified and in the case of Velcade dispensed in hospital Pharmacy Service Patients will receive a course of 4 weeks duration of Melphalan / Prednisone / Velcade consist in Melphalan, 9 mg / m2 orally daily 1-4 and Prednisone 60 mg / m2 orally on days 1 to 4, in combination Velcade with a dose of 1.3 mg / m2 sc twice weekly (days 1, 4, 8, 11), followed by 2 weeks of rest (cycle duration of 4 weeks) and seven four-week cycles duration of melphalan / prednisone / Velcade consist in Melphalan, 9 mg / m2 orally on days 1 to 4 and prednisone, 60 mg / m2 orally on days 1 to 4, in combination with Velcade, at doses of 1, 0 mg / m2 sc (days 1, 4).

Melphalan and Prednisone will be dispensed for oral administration. The Melphalan should be administered in a single two hours separately taking any food and prednisone be taken in the morning with or immediately after a meal. The amount in mg will be calculated based on the body surface, to be calculated on day 1 of each cycle. Velcade for administration, calculated on day 1 of the cycle will be the same dose throughout the entire cycle. If a patient experiences a gain or loss of remarkable weight within the cycle, the dose to be administered will be recalculated based on the new body surface. The appropriate amount of Velcadeserá dispensed in a sc injection. Velcade dose between two leave at least 72 hours


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical, Multicenter, Single-arm, Treatment With a Scheme With Low Doses of Bortezomib / Melphalan / Prednisone (MPV) in Patients With Multiple Myeloma (MM) Newly Diagnosed Symptomatic ≥75 Years
Study Start Date : January 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Velcadito
Bortezomib 1.3 mg/m2 days 1,4,8 and 11 first cycle, the 1.0 mg/m2 days 1 and 4. Melphalan 9 mg/m2 days 1 to 4 Prednisone 60 mg/m2 days 1 to 4 Cycles of 28 days
Drug: Bortezomib
Low dose of bortezomib
Other Name: Velcade

Drug: Melphalan
Drug: Prednisone



Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient should, in the investigator's opinion, be able to meet all requirements of the trial.
  • The patient must voluntarily sign informed consent before performing any test study that is not part of routine care of patients, with the knowledge that the patient can leave the study at the time you want, without being harmed at any time their aftercare.
  • Age > 75 years.
  • The patient should be diagnosed symptomatic multiple myeloma according to established criteria and may not have received any treatment for disease (see Appendix 6). Administration is permitted steroid pulses some urgency required prior to starting treatment or induction administration of bisphosphonates.

The patient must have measurable disease, defined as follows:

  • For Multiple Myeloma secretory measurable disease is defined by the presence of measurable serum monoclonal component, 1g/dL or if urinary excretion of light chains is greater than or equal to 200 mg/24 hours.
  • For Multiple Myeloma oligosecretory or secretory, serous level chain.
  • Free light affected 10 mg/dL (100 mg/L, with a ratio of abnormal free light chain serum).
  • The patient must have a life expectancy greater than 3 months life.
  • The patient must have the following laboratory values prior to initiation of treatment corresponding induction:

    • Platelet count 50000/mm3,
    • hemoglobin 8 g/dl,
    • absolute neutrophil count 1000/mm3,
    • Lower values are permitted if they are due to infiltration of the MO.

Exclusion Criteria:

  • Patients who have previously received treatment for multiple myeloma, with the exception of steroid pulses for some urgency required prior to initiating induction therapy, administration of bisphosphonates or radiotherapy either analgesic or due to the presence of plasmacytomas require it for some urgency.
  • Patients with non-measurable disease or by SFLC.
  • Patients with known hypersensitivity to bortezomib, boron or mannitol acid.
  • Patients who have received any investigational agent within 30 days prior to enrollment.
  • Patients who are currently in another clinical trial or receiving any investigational agent.
  • Hypertension or poorly controlled diabetes mellitus or other serious organic disease involving excessive risk to the patient or any psychiatric disorder that interfere with the understanding of informed consent.
  • Acute diffuse infiltrative pulmonary disease and pericardial disease.

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 ClinicalTrials.gov identifier (NCT number): NCT02773550


Contacts
Contact: Ernesto Pérez Persona 945 00 71 71 ernesto.perezpersona@osakidetza.eus
Contact: Arantza Sáez de Lafuente Moríñigo 945 00 71 13 arantza.saezdelafuentemorinigo@osakidetza.eus

Locations
Spain
Araba of University Hospital Recruiting
Vitoria-Gasteiz, Araba, Spain, 01009
Contact: Ernesto Perez Persona, MD    +34945 007171    ernesto.perezpersona@osakidetza.eus   
Contact: Arantza Sáez de Lafuente Moríñigo       arantza.saezdelafuentemorinigo@osakidetza.eus   
Sponsors and Collaborators
Basque Health Service
Investigators
Study Director: Ernesto Pérez Persona Hospital Universitario Araba (Sede Txogoriritxu)

Responsible Party: Ernesto Perez Persona, Doctor, Basque Health Service
ClinicalTrials.gov Identifier: NCT02773550     History of Changes
Other Study ID Numbers: Velcadito
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ernesto Perez Persona, Basque Health Service:
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
Prednisone
Bortezomib
Melphalan
Anti-Inflammatory Agents
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
Immunosuppressive Agents
Immunologic Factors