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

NCT00378755 | Unknown Phase 2

• 2 other identifiers: KMM5126866138MMY2028
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Secondary Objectives
3. 3.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
4. 4.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.

Conditions

Multiple Myeloma

Keywords

velcade; myeloma; VAD regimen; Transplantation, Autologous

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• the progression free survival

• duration of response

• overall survival

• toxicities

Interventions

velcade DRUG

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• Korean Multiple Myeloma Working Party: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sung-Soo Yoon, MD PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung-Soo Yoon, MD PhD

CONTACT

82-2-2072-3079; ssysmc@snu.ac.kr

Inho Kim, MD PhD

CONTACT

82-2-2072-0834; kim_dajung@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 21, 2006
• Study Start: March 1, 2006
• Study Completion: July 1, 2008
• Last Updated: September 22, 2006

Record last verified: 2006-09

Locations

KR (1)