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Multiple MyelomaPhase 2NCT01190787

Subcutaneous Velcade Plus Oral Melphalan and Prednisone or Plus Cycloposphamide and Prednisone or Plus Prednisone

A Phase 2 study testing velcade subcutaneous melphalan prednisone, velcade cyclophosphamide prednisone and velcade prednisone in people with Multiple Myeloma, run by European Myeloma Network B.V. 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

This protocol is a single-arm, three-cohort, phase II multicenter study designed to assess the safety and the efficacy of three all-oral combinations: Velcade with continuous low-dose melphalan and prednisone (VMP) or with continuous low-dose cyclophosphamide and prednisone (VCP) or Velcade with low-dose prednisone… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
velcade subcutaneous melphalan prednisone, velcade cyclophosphamide prednisone and velcade prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteItaly
Study dates
Jul 2010to 18 Jan 2024
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 75 years old or age < 75 years with abnormal cardiac, pulmonary, renal or hepatic function (unsuitable for protocol with standard inclusion/exclusion criteria).
  • 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 Velcade 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 therapy.
  • Patient was a newly diagnosed multiple myeloma based on standard criteria
Show all 19Show fewer
  • 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
  • Pretreatment clinical laboratory values within 14 days of enrolment:
  • platelet count ≥ 80x109/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
  • cleareance creatinine ≥ 20 ml/min

Who cannot join

  • 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
  • Peripheral neuropathy or neuropatic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 3.0
  • Infiltrative pulmonary disease

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • A.O.U. Città della Salute e della Scienza di Torino - SC Ematologia U

    Torino, 10126

Other trials in Italy

About this study

Official title: A Multicenter Phase II Study of Subcutaneous Velcade Plus Oral Melphalan and Prdnisone or Plus Cycloposphamide and Prednisone or Plus Prednisone in Newly Diagnosed Elderly Multiple Myeloma Patients

This protocol is a single-arm, three-cohort, phase II multicenter study designed to assess the safety and the efficacy of three all-oral combinations: Velcade with continuous low-dose melphalan and prednisone (VMP) or with continuous low-dose cyclophosphamide and prednisone (VCP) or Velcade with low-dose prednisone could be effective and well tolerated (VP).

Read the detailed description

This protocol is a single-arm, three-cohort, phase II multicenter study designed to assess the safety and the efficacy of VMP and VCP and VP as up-front treatment in elderly MM patients. The combination of weekly subcutaneous administrations of Velcade with continuous low-dose melphalan and prednisone (VMP) or with continuous low-dose cyclophosphamide and prednisone (VCP) or Velcade with low-dose prednisone could be effective and well tolerated (VP).

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

The pre-treatment period includes screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility. The screening period includes the availability of inclusion criteria described above.

The treatment period includes induction and maintenance.

Subjects receive:

  1. Induction therapy: nine 4-week courses of Velcade/Melphalan/Prednisone (VMP) or nine 4-week courses of Velcade/Cyclophosphamide/Prednisone (VCP) or Nine 4-week courses of Velcade/Prednisone (VP).
  2. Maintenance therapy:

Velcade alone During the induction period patients will attend periodic study centre visits each scheduled Velcade administration in order to asses the toxicity and efficacy of the treatment. During the maintenance period, all patients will attend study centre visits every 4 weeks, until development of confirmed PD. The response will be assessed after each cycle.

During the LTFU period, after development of confirmed PD, all patients are to be followed for survival during the LTFU period every 3 months via telephone or office visit.

The duration of treatment period, including the maintenance treatment is approximately 3 years. The duration of LTFU is approximately 2 years, for a total of 5 years. the occurance of PD will determine the duration of progression-free survival of each patient(secondary objective). The occurrence of death will determine the duration of overall survival (secondary objective).

Being tested
velcade subcutaneous melphalan prednisone, velcade cyclophosphamide prednisone, velcade prednisone
Keywords
Multiple Myeloma, Elderly Patients, Diagnosis, Velcade subcutaneous, Prednisone, Melphalan, Cyclophosphamide
Medical subject headings
Multiple Myeloma, Disease

What participants receive

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

  • velcade subcutaneous melphalan prednisoneDrug

    Also called Bortezomib, Alkeran, Deltacortene

    INDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days.

    Melphalan will be given orally. Each cycle will be repeated every 28 days. Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days.

  • velcade cyclophosphamide prednisoneDrug

    Also called Bortezomib,Endoxan, deltacortene

    INDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days.

    Cyclophosphamide will be given orally. Each cycle will be repeated every 28 days.

    Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days.

  • velcade prednisoneDrug

    Also called Bortezomib, deltacortene

    INDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days.

    Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days.

Study groups in NCT01190787
Study groupRoleWhat they receive
VMPExperimentalINDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days. Melphalan will be given orally. Each cycle will be repeated every 28 days. Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days.
Receives: Drug: velcade subcutaneous melphalan prednisone
VCPExperimentalINDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days. Cyclophosphamide will be given orally. Each cycle will be repeated every 28 days. Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days.
Receives: Drug: velcade cyclophosphamide prednisone
VPExperimentalINDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days. Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days.
Receives: Drug: velcade prednisone

What is being measured

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

  1. Very Good Partial Response, Complete response rate , Partial response rate

    Measured: 5 years

Secondary outcomes (7)

  1. Progression free survival

    Measured: 5 years

  2. Time to progression

    Measured: 5 years

  3. Time to Next Therapy

    Measured: 5 years

  4. Overall survival

    Measured: 5 years

  5. Time to response

    Measured: 5 years

  6. Duration of response

    Measured: 5 years

  7. Response rate

    Measured: 5 years

Timeline

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

  1. First posted30 Aug 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionMay 2012
  4. Study completion18 Jan 2024

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01190787
Sponsor's protocol ID
26866138MMY2069
Status last verified
Jan 2024
First submitted
27 Aug 2010
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • Palumbo A, Bringhen S, Mateos MV, Larocca A, Facon T, Kumar SK, Offidani M, McCarthy P, Evangelista A, Lonial S, Zweegman S, Musto P, Terpos E, Belch A, Hajek R, Ludwig H, Stewart AK, Moreau P, Anderson K, Einsele H, Durie BG, Dimopoulos MA, Landgren O, San Miguel JF, Richardson P, Sonneveld P, Rajkumar SV. Geriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group report. Blood. 2015 Mar 26;125(13):2068-74. doi: 10.1182/blood-2014-12-615187. Epub 2015 Jan 27.

    PubMed 25628469

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing velcade subcutaneous melphalan prednisone, velcade cyclophosphamide prednisone and velcade prednisone in people with Multiple Myeloma, run by European Myeloma Network B.V. 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 19 inclusion and 6 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 23 Jan 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Very Good Partial Response, Complete response rate , Partial response rate (time frame: 5 years). 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 NCT01190787, which also lists 2 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 23 Jan 2024.

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