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Velcade®, Thalidomide, Dexamethasone (VTD) Induction Therapy Followed By Melphalan, Prednisone, Thalidomide (MPT) Maintenance As a First Line Treatment For The Patients With Multiple Myeloma Who Are Non-Transplant Candidates


Phase 2
65 Years
75 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

Velcade®, Thalidomide, Dexamethasone (VTD) Induction Therapy Followed By Melphalan, Prednisone, Thalidomide (MPT) Maintenance As a First Line Treatment For The Patients With Multiple Myeloma Who Are Non-Transplant Candidates


The two effective and non-cross resistant regimens, VTD and MPT, will be applied
sequentially to the patients with multiple myeloma who are not transplant candidates. This
would be expected to result in maximal tumor control, and thus, in maximal survival benefit,
equivalent to high dose therapy with autologous transplantation in younger population


Inclusion Criteria:



- Newly diagnosed patients with overt multiple myeloma who are not candidates for
HDT/SCT because of old age (> 65) or presence of comorbid conditions likely to have a
negative impact on tolerability of HDT/SCT. Sponsors review this conditions and
approval is required.

- Presence of measurable disease : serum M-protein > 1g/dL or urine M- protein >
400mg/day

- Performance status £ ECOG 2

- Expected survival ³ 6 months

- Pretreatment clinical laboratory values meeting the following criteria within 14 days
before enrollment platelet ≥ 100 x 109/L hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L) Prior
RBC transfusion or recombinant human erythropoietin use is allowed) absolute
neutrophil count (ANC) ≥ 1.0 x 109/L aspartate aminotransferase (AST) ≤ 2.5 times the
upper limit of normal alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of
normal total bilirubin ≤ 1.5 times the upper limit of normal serum creatinine ≤
3mg/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.

Exclusion Criteria:

- Smoldering or indolent myeloma

- History of allergic reaction attributable to compounds containing boron or mannitol

- Known hypersensitivity to thalidomide or dexamethasone

- Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE
version 3

- Uncontrolled or severe cardiovascular disease, including MI within 6 months of
enrolment, New York Heart Association (NYHA) Class III or IV heart failure,
uncontrolled angina, clinically significant pericardial disease, or cardiac
amyloidosis, cardiac ejection fraction <0.5 : Severe conduction disorder :
Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg

- Sepsis

- Pregnancy or breastfeeding

- Uncontrolled Diabetes Mellitus

- Recurrent DVT or pulmonary embolism

- Active ulcers detected by gastroscopy

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

- Receipt of extensive radiation therapy within 4 weeks

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate of VTD induction Therapy

Outcome Time Frame:

2008-02-01

Safety Issue:

Yes

Principal Investigator

Jae Hoon Lee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gachon University Gil Hospital

Authority:

Singapore: Domain Specific Review Boards

Study ID:

KMM52

NCT ID:

NCT00320476

Start Date:

April 2006

Completion Date:

February 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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