Know Cancer

or
forgot password

A Phase II, Multi-Center, Open Label Study Of Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase II, Multi-Center, Open Label Study Of Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients


In Multiple Myeloma (MM) patients, the conventional treatment is the oral combination
melphalan and prednisone (MP). thalidomide has been widely used in myeloma, it has been
proved clinical effective in refractory myeloma patients, it acts sinergistically in
association with dexamethasone. In newly diagnosed patients, the combination oral MP plus
thalidomide increased the partial and complete response rate.Bortezomib represents a novel
class of anti-cancer drugs, it is active in patient with multiple myeloma who are refractory
to conventional chemotherapy. In a preliminary report, the combination of VELCADE and
Thalidomide induced a remarkable 60% PR rate in advanced refractory myeloma patients. This
study will evaluate the safety and the efficacy of the association of Melphalan/
Prednisone/Thalidomide/VELCADE (MPTV) as salvage treatment in advanced and refractory
myeloma patients. This association might further increase the response rate achieved by the
standard oral MP regimen.


Inclusion Criteria:



- Patient is of a legally consenting age as defined by local regulations.

- 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consent may be withdrawn by the patient at any time without prejudice to their future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.

- Female patient is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study.

- Male patient agrees to use an acceptable method for contraception (i.e., condom or
abstinence) for the duration of the study.

- Patient was previously diagnosed with multiple myeloma based on standard criteria.

- Patient is relapsed or refractory after one or two lines of treatment including
high-dose chemotherapy with stem cell support, conventional poli-chemotherapy,
thalidomide- and melphalan-based regimens.

- Patient has measurable disease, defined as follows: 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.

- Patient has a Karnofsky performance status ≥60%.

- Patient has a life-expectancy >3 months.

- Patient has the following laboratory values within 14 days before Baseline (day 1 of
the Cycle 1, before study drug administration):

- Platelet count ≥75 x 109/L without transfusion support within 7 days before the test.

- Absolute neutrophil count (ANC) ≥ 0.75 x 109/L without the use of growth factors.

- Corrected serum calcium ≤14 mg/dL (3.5 mmol/L).

- Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN).

- Alanine transaminase (AST): ≤ 2.5 x the ULN.

- Total bilirubin: ≤ 1.5 x the ULN.

- Calculated or measured creatinine clearance: ≥20 mL/minute.

Exclusion Criteria:

- Patient has an absolute neutrophil count <0.75 × 109/L within 14 days before enrollment.

- Patient has a calculated or measured creatinine clearance <20 mL/minute within 14
days before enrollment.

- Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment.

- Patient has known hypersensitivity to bortezomib, boron, mannitol or thalidomide.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

SAFETY AND EFFICACY

Principal Investigator

MARIO BOCCADORO, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

DIVISIONE DI EMATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY

Authority:

Italy: Ministry of Health

Study ID:

X05141

NCT ID:

NCT00358020

Start Date:

November 2004

Completion Date:

December 2008

Related Keywords:

  • Multiple Myeloma
  • MYELOMA, THALIDOMIDE, BORTEZOMIB
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location