Sequential VAD and VTD Followed by HDT With ASCT and Velcade Maintenance for NDMM

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Korean Multiple Myeloma Working Party.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by:
Korean Multiple Myeloma Working Party
ClinicalTrials.gov Identifier:
NCT00378755
First received: September 20, 2006
Last updated: September 21, 2006
Last verified: September 2006

September 20, 2006
September 21, 2006
March 2006
Not Provided
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
Same as current
Complete list of historical versions of study NCT00378755 on ClinicalTrials.gov Archive Site
  • the progression free survival
  • duration of response
  • overall survival
  • toxicities
Same as current
Not Provided
Not Provided
 
Sequential VAD and VTD Followed by HDT With ASCT and Velcade Maintenance for NDMM
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. Primary Objective To assess the 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
  2. Secondary Objectives

    1. To assess the progression free survival, duration of response, and overall survival of patients given sequential VAD and VTD induction followed by high dose therapy with autologous stem cell transplantation and maintenance treatment with Velcade
    2. To assess the toxicities of sequential VAD and VTD induction chemotherapy, high dose therapy with autologous stem cell transplantation, and of maintenance treatment with Velcade.
  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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: velcade
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
July 2008
Not Provided

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).
Both
15 Years to 65 Years
No
Contact: Sung-Soo Yoon, MD PhD 82-2-2072-3079 ssysmc@snu.ac.kr
Contact: Inho Kim, MD PhD 82-2-2072-0834 kim_dajung@hanmail.net
Korea, Republic of
 
NCT00378755
KMM51, 26866138MMY2028
Not Provided
Not Provided
Korean Multiple Myeloma Working Party
Janssen-Cilag Ltd.
Principal Investigator: Sung-Soo Yoon, MD PhD Seoul National University Hospital
Korean Multiple Myeloma Working Party
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP