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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: velcade	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	62 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	March 2006
Study Completion Date :	July 2008

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. the progression free survival
2. duration of response
3. overall survival
4. toxicities

Eligibility Criteria

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Ages Eligible for Study:	15 Years to 65 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

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Contacts

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

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Korean Multiple Myeloma Working Party

Janssen-Cilag Ltd.

Investigators

Principal Investigator:	Sung-Soo Yoon, MD PhD	Seoul National University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00378755 History of Changes
Other Study ID Numbers:	KMM51; 26866138MMY2028
First Posted:	September 21, 2006
Last Update Posted:	September 22, 2006
Last Verified:	September 2006

Keywords provided by Korean Multiple Myeloma Working Party:

velcade; myeloma; VAD regimen; Transplantation, Autologous

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias	Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Bortezomib; Antineoplastic Agents