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

January 14, 2020 updated by: Ernesto Perez Persona, Basque Health Service

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Araba
      • Vitoria-Gasteiz, Araba, Spain, 01009
        • Araba of University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Prednisone
Drug: Melphalan
Drug: Bortezomib
Low dose of bortezomib
Other Names:
  • Velcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basque Health Service

Investigators

  • Study Director: Ernesto Pérez Persona, Hospital Universitario Araba (Sede Txogoriritxu)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Velcadito

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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