Velcade, Melphalan, Prednisone And Thalidomide Versus Velcade, Melphalan, Prednisone in Multiple Myeloma Patients

June 28, 2023 updated by: Fondazione EMN Italy Onlus

A PHASE III, MULTI-CENTER, RANDOMIZED OPEN LABEL STUDY OF VELCADE, MELPHALAN, PREDNISONE AND THALIDOMIDE (V-MPT) Versus VELCADE, MELPHALAN, PREDNISONE (V-MP) IN ELDERLY UNTREATED MULTIPLE MYELOMA PATIENTS

The proposed study will evaluate whether the combination of VELCADE, Thalidomide , Melphalan and Prednisone (V-MPT), as induction treatment for newly diagnosed elderly MM patients, improves outcomes compared to the combination VELCADE-MP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This phase III study represents a prospective randomized open label multicenter trial to evaluate whether the combination of VELCADE, Melphalan, Prednisone and Thalidomide (V-MPT), as induction treatment for newly diagnosed elderly MM patients, improves outcomes compared to the combination VELCADE-MP.

Subjects will be randomized in a 1:1 allocation between:

Arm A: 250 patients: V-MPT treatment Arm B: 250 patients: V-MP treatment Patients excluded from randomization are to be registered in Arm C. Patients randomized in arm A (Thalidomide based) will be further enrolled in the sub-study about the DVT prophylaxis.

Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment, treatment and long-term follow-up (LTFU).

  1. Pre-treatment period:

    Screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility After registration subjects will be randomized.

  2. Treatment period:

    Subjects in Arm A will receive:

    1. Induction therapy:

      nine 5-week courses of VELCADE/Melphalan/Prednisone/Thalidomide (V-MPT)

    2. Maintenance therapy:

    Thalidomide in combination with VELCADE

    Subjects in Arm B will receive:

    1. Induction therapy:

      nine 5-week courses of VELCADE/Melphalan/Prednisone (V-MP)

    2. No maintenance therapy is scheduled At the end of induction treatment or at the time of discontinuation of all study drugs, all patients are to attend study center visits on an every 6 to 8-week basis, until development of confirmed Progressive Disease (PD)
  3. LTFU period:

After development of confirmed PD all patients are to be followed for survival every 3 months via telephone or office visit.

Study Type

Interventional

Enrollment (Actual)

511

Phase

  • Phase 3

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

  • Italy
      • Torino, Italy, 10126
        • A.O.U. S. Giovanni Battista

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

18 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 65 year old and not a candidate for stem cell transplant, or younger who refuses or is not eligible for high-dose therapy
  • Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage
  • Presence of measurable disease
  • Karnofsky performance status (PS) > 60%
  • Able to read and complete the HRQOL instruments
  • Agrees to use an acceptable barrier method for contraception for the duration of the study
  • Pretreatment clinical laboratory values within 14 days of randomization:

platelet count ≥ 100x109/L

  • hemoglobin ≥ 8 g/dL
  • absolute neutrophil count (ANC) ≥ 1.0x109/L
  • AST ≤ 2.5 times the upper limit of normal
  • ALT ≤ 2.5 times the upper limit of normal
  • total bilirubin ≤ 1.5 times the upper limit of normal
  • serum creatinine ≤ 2.5mg/dL
  • corrected serum calcium <14 mg/dL (<3.5 mmol/L)
  • Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
  • Women of child-bearing potential must agree to use 2 methods of contraception: 1 effective (for example hormonal or tubal ligation) and 1 barrier (for example latex condom, diaphragm) for at least 4 weeks before starting the therapy, during the Treatment Period, and for 4 weeks after the last dose;
  • Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity during the Treatment Period and for 4 weeks after the last dose.

Exclusion Criteria:

  • Diagnosis of smoldering multiple myeloma or MGUS.
  • Diagnosis of Waldenstrom's disease
  • Prior or current systemic therapy for multiple myeloma including steroids (with exception of emergency use of a short course [maximum 4 days] of steroids before randomization or prior or current use of biphosphonates)
  • Radiation therapy within 30 days before randomization
  • Plasmapheresis within 30 days before randomization
  • Major surgery within 30 days before randomization (Kyphoplasty is not considered major surgery)
  • History of allergic reaction attributable to compounds containing boron or mannitol, or to Thalidomide
  • Peripheral neuropathy Grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 3.0
  • Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
  • Other malignancy within the past 5 years. Exceptions: basal cell or non metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or FIGO Stage 1 carcinoma of the cervix
  • Concurrent medical condition or disease (e.g., active systemic infection, uncontrolled diabetes, pulmonary disease) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
  • Use of any investigational drugs within 30 days before randomization.
  • Pregnant or lactating women. A serum β-hCG pregnancy test must be performed at the Screening visit, for female patients of child-bearing potential. If the test is positive, the patient must be excluded from the study. Confirmation that the patient is not pregnant must be established by a negative serum or urinary pregnancy test with the result obtained 1 day prior to the Baseline visit (or the day of the visit if results are available before drug delivery).

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: VMPT
Induction therapy with nine 5-week courses of VELCADE/Melphalan/Prednisone/Thalidomide (V-MPT) followed by maintenance therapy with Thalidomide and VELCADE
Drug: Bortezomib, Melphalan, Prednisone, Thalidomide

Induction therapy:

9 courses with weekly VELCADE (4 doses) in combination with oral Melphalan 9 mg/m2,oral Prednisone 60 mg/m2 once daily on Days 1 to 4 of each course and Thalidomide 50 mg/day continuously. The dose of VELCADE is 1.3 mg/m2 administered as a bolus IV injection, on days 1, 8, 15, 22.

Maintenance therapy:

Thalidomide 50 mg/day continuously in combination with VELCADE 1.3 mg or maximum dose tolerated/m2/2 weeks. The maintenance will be initiated at the end of the 9th course and will be stopped after progression. The median expected duration of the maintenance treatment is approximately 2 years.

Other Names:
  • Velcade
  • Bortezomib
  • Thalidomide
Active Comparator: VMP

Induction therapy with nine 5-week courses of either VELCADE/Melphalan/Prednisone (V-MP).

No maintenance is scheduled.
Drug: Bortezomib, Melphalan, Prednisone
Induction therapy: 9 courses with weekly VELCADE(4 doses) in combination with oral Melphalan 9 mg/m2 and oral Prednisone 60 mg/m2 once daily on Days 1 to 4 of each course. No maintenance therapy is scheduled
Other Names:
  • Boirtezomib
  • velcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine whether the V-MPT combination improves progression free survival (PFS)
Time Frame: Approximately 24 months
Approximately 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine whether the VMPT combination improves:Response rate, Overall Survival rate, Time and duration of response, Assess the safety, Assess the prognostic factors
Time Frame: Approximately 24 months
Approximately 24 months

Collaborators and Investigators

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

Sponsor

Fondazione EMN Italy Onlus

Investigators

  • Principal Investigator: Mario Boccadoro, MD, Divisione di Ematologia dell'Università di Torino, A.O.U. S. Giovanni Battista, Torino;Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2006

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimated)

February 5, 2010

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIMEMA-MM-03-05
  • 2005-004745-33 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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