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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

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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 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

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

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).

Inclusion Criteria:

- Age ≥ 75 years old or age < 75 years with abnormal cardiac, pulmonary, renal or
hepatic function (unsuitable for protocol with standard inclusion/exclusion

- 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

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Antonio Palumbo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Hematology, A.O.U. San Giovanni Battista


Italy: Ethics Committee

Study ID:




Start Date:

July 2010

Completion Date:

August 2015

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Elderly Patients
  • Diagnosis
  • Velcade subcutaneous
  • Prednisone
  • Melphalan
  • Cyclophosphamide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell