Clinical trial NCT00378755: Sequential VAD and VTD Followed by HDT With ASCT and Velcade Maintenance for NDMM
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: velcade
myeloma
VAD regimen
Transplantation, Autologous
Lead sponsor: Korean Multiple Myeloma Working Party
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Ltd.
First posted: 2006-09-21
Enrollment: 62
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
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
Secondary outcomes:
measure: the progression free survival
measure: duration of response
measure: overall survival
measure: toxicities
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sung-Soo Yoon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: