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Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VTD (Velcade, Thalidomide, Dexamethasone) Induction Followed by HDT With ASCT and Maintenance Treatment With Velcade for Newly Diagnosed MM


Phase 2
15 Years
65 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VTD (Velcade, Thalidomide, Dexamethasone) Induction Followed by HDT With ASCT and Maintenance Treatment With Velcade for Newly Diagnosed MM


1. Overview of study design

This study aims to assess the efficacy and toxicities of sequential VAD and VTD
induction followed by high dose therapy with autologous stem cell transplantation and
maintenance treatment with velcade as a first line treatment for the patients with
multiple myeloma. This study will be conducted as an open, multi-center, single arm,
prospective phase 2 study.

2. Sample size determination

The expected response rate of sequential VAD and VTD induction chemotherapy as a first
line treatment for the patients with multiple myeloma is 80%. By using Flemming’s
single stage design ( error: 0.05,  error : 0.2), 55 evaluable patients are needed to
prove this hypothesis. If withdrawal rate is 10%, enrollment of total 62 patients will
be needed.

3. Duration of the Study

One year of enrollment will be needed (2006.03.1-2007.02.28). At least 24 months of
follow-up for the patients who are to be enrolled last time is needed.


Inclusion Criteria:



- 1.Previously untreated newly diagnosed patients with MM (stage II-III) 2.Age < 65
3.Eastern Cooperative Oncology Group Performance Status 0-1 4.EF > 50%, FVC and FEV >
50%, DLCO >50% 5.Platelet count ≥ 100 x 109/L (pretreatment platelet transfusion is
not allowed, while transfusion during the treatment is permitted), 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 6.Adequate liver function
(bilirubin < UNL(Upper Normal Limit) x 2 and ALT/AST < UNL x 3) 7.Adequate renal
function (serum creatinine < UNL x 1.5 or creatine clearance > 60 ml/min) 8.Signed
the informed consent, have the will and ability to follow the protocol

Exclusion Criteria:

- 1. History of allergic reaction attributable to compounds containing boron or
mannitol 2. Known hypersensitivity to thalidomide or dexamethasone 3. Peripheral
neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 4.
Uncontrolled or severe cardiovascular disease, including MI within 6 months of
enrollment, New York Heart Association (NYHA) Class III or IV heart failure,
uncontrolled angina, clinically significant pericardial disease, or cardiac
amyloidosis 5. Acute severe infection requiring antibiotic therapy 6. Previous cancer
history (except in situ carcinoma of cervix or basal cell cancer of skin) 7.
Pregnancy or breastfeeding 8. Active ulcer detected by gastroscopy (gastroscopy is
not routine in all patients, only to patients with symptoms of ulcer disease and/or
history of previous ulcer therapy and/or physician's discretion) 9. Previous renal
transplantation 10. Recurrent deep vein thrombosis or pulmonary embolism 11.
Uncontrolled diabetes mellitus 12. Receipt of extensive radiation therapy within 4
weeks ((Extensive means RT to more than 2 anatomic sites).

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:

response rate of sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VTD (Velcade, Thalidomide, Dexamethasone) induction therapy as a first line treatment for the patients with multiple myeloma

Principal Investigator

Sung-Soo Yoon, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Singapore: Domain Specific Review Boards

Study ID:

KMM51

NCT ID:

NCT00378755

Start Date:

March 2006

Completion Date:

July 2008

Related Keywords:

  • Multiple Myeloma
  • velcade
  • myeloma
  • VAD regimen
  • Transplantation, Autologous
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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