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Multiple MyelomaPhase 3NCT01063179

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

A Phase 3 study testing Bortezomib, Melphalan, Prednisone, Thalidomide and Bortezomib, Melphalan, Prednisone in people with Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 to 100 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Bortezomib, Melphalan, Prednisone, Thalidomide and Bortezomib, Melphalan, Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
511 participants
Where
1 siteItaly
Study dates
May 2006to Jul 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 100 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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).

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • A.O.U. S. Giovanni Battista

    Torino, 10126

Other trials in Italy

About this study

Official title: 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.

Read the 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:
  3. Induction therapy: nine 5-week courses of VELCADE/Melphalan/Prednisone/Thalidomide (V-MPT)
  4. Maintenance therapy: Thalidomide in combination with VELCADE Subjects in Arm B will receive:
  5. Induction therapy: nine 5-week courses of VELCADE/Melphalan/Prednisone (V-MP)
  6. 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)
  7. LTFU period:

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

Being tested
Bortezomib, Melphalan, Prednisone, Thalidomide, Bortezomib, Melphalan, Prednisone
Keywords
Elderly patients, Bortezomib, Thalidomide
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bortezomib, Melphalan, Prednisone, ThalidomideDrug

    Also called Bortezomib, Velcade, 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.

  • Bortezomib, Melphalan, PrednisoneDrug

    Also called Boirtezomib, velcade

    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

Study groups in NCT01063179
Study groupRoleWhat they receive
Arm A: VMPTExperimentalInduction therapy with nine 5-week courses of VELCADE/Melphalan/Prednisone/Thalidomide (V-MPT) followed by maintenance therapy with Thalidomide and VELCADE
Receives: Drug: Bortezomib, Melphalan, Prednisone, Thalidomide
VMPActive comparatorInduction therapy with nine 5-week courses of either VELCADE/Melphalan/Prednisone (V-MP). No maintenance is scheduled.
Receives: Drug: Bortezomib, Melphalan, Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine whether the V-MPT combination improves progression free survival (PFS)

    Measured: Approximately 24 months

Secondary outcomes (1)

  1. Determine whether the VMPT combination improves:Response rate, Overall Survival rate, Time and duration of response, Assess the safety, Assess the prognostic factors

    Measured: Approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2010 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01063179
Sponsor's protocol ID
GIMEMA-MM-03-05
Other IDs
2005-004745-33, 2005
Status last verified
Jun 2023
First submitted
4 Feb 2010
Last updated
29 Jun 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Larocca A, Mina R, Offidani M, Liberati AM, Ledda A, Patriarca F, Evangelista A, Spada S, Benevolo G, Oddolo D, Innao V, Cangiolosi C, Bernardini A, Musto P, Amico V, Fraticelli V, Paris L, Giuliani N, Falcone AP, Zambello R, De Paoli L, Romano A, Palumbo A, Montefusco V, Hajek R, Boccadoro M, Bringhen S. First-line therapy with either bortezomib-melphalan-prednisone or lenalidomide-dexamethasone followed by lenalidomide for transplant-ineligible multiple myeloma patients: a pooled analysis of two randomized trials. Haematologica. 2020 Apr;105(4):1074-1080. doi: 10.3324/haematol.2019.220657. Epub 2019 Jun 27.

    PubMed 31248973

  • Montefusco V, Gay F, Spada S, De Paoli L, Di Raimondo F, Ribolla R, Musolino C, Patriarca F, Musto P, Galieni P, Ballanti S, Nozzoli C, Cascavilla N, Ben-Yehuda D, Nagler A, Hajek R, Offidani M, Liberati AM, Sonneveld P, Cavo M, Corradini P, Boccadoro M. Outcome of paraosseous extra-medullary disease in newly diagnosed multiple myeloma patients treated with new drugs. Haematologica. 2020 Jan;105(1):193-200. doi: 10.3324/haematol.2019.219139. Epub 2019 Jun 20.

    PubMed 31221778

  • Saltarella I, Morabito F, Giuliani N, Terragna C, Omede P, Palumbo A, Bringhen S, De Paoli L, Martino E, Larocca A, Offidani M, Patriarca F, Nozzoli C, Guglielmelli T, Benevolo G, Callea V, Baldini L, Grasso M, Leonardi G, Rizzo M, Falcone AP, Gottardi D, Montefusco V, Musto P, Petrucci MT, Dammacco F, Boccadoro M, Vacca A, Ria R. Prognostic or predictive value of circulating cytokines and angiogenic factors for initial treatment of multiple myeloma in the GIMEMA MM0305 randomized controlled trial. J Hematol Oncol. 2019 Jan 9;12(1):4. doi: 10.1186/s13045-018-0691-4.

    PubMed 30626425

  • Cerrato C, Di Raimondo F, De Paoli L, Spada S, Patriarca F, Crippa C, Mina R, Guglielmelli T, Ben-Yehuda D, Oddolo D, Nozzoli C, Angelucci E, Cascavilla N, Rizzi R, Rocco S, Baldini L, Ponticelli E, Marcatti M, Cangialosi C, Caravita T, Benevolo G, Ria R, Nagler A, Musto P, Tacchetti P, Corradini P, Offidani M, Palumbo A, Petrucci MT, Boccadoro M, Gay F. Maintenance in myeloma patients achieving complete response after upfront therapy: a pooled analysis. J Cancer Res Clin Oncol. 2018 Jul;144(7):1357-1366. doi: 10.1007/s00432-018-2641-5. Epub 2018 Apr 19.

    PubMed 29675792

  • Caltagirone S, Ruggeri M, Aschero S, Gilestro M, Oddolo D, Gay F, Bringhen S, Musolino C, Baldini L, Musto P, Petrucci MT, Gaidano G, Passera R, Bruno B, Palumbo A, Boccadoro M, Omede P. Chromosome 1 abnormalities in elderly patients with newly diagnosed multiple myeloma treated with novel therapies. Haematologica. 2014 Oct;99(10):1611-7. doi: 10.3324/haematol.2014.103853. Epub 2014 Jul 11.

    PubMed 25015938

  • Palumbo A, Bringhen S, Larocca A, Rossi D, Di Raimondo F, Magarotto V, Patriarca F, Levi A, Benevolo G, Vincelli ID, Grasso M, Franceschini L, Gottardi D, Zambello R, Montefusco V, Falcone AP, Omede P, Marasca R, Morabito F, Mina R, Guglielmelli T, Nozzoli C, Passera R, Gaidano G, Offidani M, Ria R, Petrucci MT, Musto P, Boccadoro M, Cavo M. Bortezomib-melphalan-prednisone-thalidomide followed by maintenance with bortezomib-thalidomide compared with bortezomib-melphalan-prednisone for initial treatment of multiple myeloma: updated follow-up and improved survival. J Clin Oncol. 2014 Mar 1;32(7):634-40. doi: 10.1200/JCO.2013.52.0023. Epub 2014 Jan 21.

    PubMed 24449241

  • Morabito F, Gentile M, Mazzone C, Rossi D, Di Raimondo F, Bringhen S, Ria R, Offidani M, Patriarca F, Nozzoli C, Petrucci MT, Benevolo G, Vincelli I, Guglielmelli T, Grasso M, Marasca R, Baldini L, Montefusco V, Musto P, Cascavilla N, Majolino I, Musolino C, Cavo M, Boccadoro M, Palumbo A. Safety and efficacy of bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide maintenance (VMPT-VT) versus bortezomib-melphalan-prednisone (VMP) in untreated multiple myeloma patients with renal impairment. Blood. 2011 Nov 24;118(22):5759-66. doi: 10.1182/blood-2011-05-353995. Epub 2011 Sep 27.

    PubMed 21951682

  • Gay F, Larocca A, Wijermans P, Cavallo F, Rossi D, Schaafsma R, Genuardi M, Romano A, Liberati AM, Siniscalchi A, Petrucci MT, Nozzoli C, Patriarca F, Offidani M, Ria R, Omede P, Bruno B, Passera R, Musto P, Boccadoro M, Sonneveld P, Palumbo A. Complete response correlates with long-term progression-free and overall survival in elderly myeloma treated with novel agents: analysis of 1175 patients. Blood. 2011 Mar 17;117(11):3025-31. doi: 10.1182/blood-2010-09-307645. Epub 2011 Jan 12.

    PubMed 21228328

  • Bringhen S, Larocca A, Rossi D, Cavalli M, Genuardi M, Ria R, Gentili S, Patriarca F, Nozzoli C, Levi A, Guglielmelli T, Benevolo G, Callea V, Rizzo V, Cangialosi C, Musto P, De Rosa L, Liberati AM, Grasso M, Falcone AP, Evangelista A, Cavo M, Gaidano G, Boccadoro M, Palumbo A. Efficacy and safety of once-weekly bortezomib in multiple myeloma patients. Blood. 2010 Dec 2;116(23):4745-53. doi: 10.1182/blood-2010-07-294983. Epub 2010 Aug 31.

    PubMed 20807892

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bortezomib, Melphalan, Prednisone, Thalidomide and Bortezomib, Melphalan, Prednisone in people with Multiple Myeloma, run by Fondazione EMN Italy Onlus at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine whether the V-MPT combination improves progression free survival (PFS) (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01063179, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

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