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

NCT01190787 | Completed Phase 2 DMC

• 1 other identifier: 26866138MMY2069
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 could be effective and well tolerated (VP).

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Elderly Patients; Diagnosis; Velcade subcutaneous; Prednisone; Melphalan; Cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• Very Good Partial Response, Complete response rate , Partial response rate

  5 years

Secondary Outcomes (7)

• Progression free survival

  5 years

• Time to progression

  5 years

• Time to Next Therapy

  5 years

• Overall survival

  5 years

• Time to response

  5 years

Study Arms (3)

VMP

EXPERIMENTAL

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.

Drug: velcade subcutaneous melphalan prednisone

VCP

EXPERIMENTAL

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.

Drug: velcade cyclophosphamide prednisone

VP

EXPERIMENTAL

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.

Drug: velcade prednisone

Interventions

velcade subcutaneous melphalan prednisone DRUG

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.

Also known as: Bortezomib, Alkeran, Deltacortene

VMP

velcade cyclophosphamide prednisone DRUG

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.

Also known as: Bortezomib,Endoxan, deltacortene

VCP

velcade prednisone DRUG

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.

Also known as: Bortezomib, deltacortene

VP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• European Myeloma Network B.V.: lead
• Fondazione EMN Italy Onlus: collaborator

Study Sites (1)

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

Torino, 10126, Italy

Location

Related Publications (2)

• 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.

  PMID: 31221778 DERIVED

• 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.

  PMID: 25628469 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Disease

Interventions

Bortezomib; Melphalan; deltacortene; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds

Study Officials

• Mario Boccadoro, MD

  Fondazione EMN Italy Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: January 18, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

IT (1)