VTD Followed By MPT Maintenance As a First Line Treatment For The Patients With MM Who Are Non-Transplant Candidates

NCT00320476 | Completed Phase 2 DMC

• 2 other identifiers: KMM5226866138MMY2027
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Myeloma is a incurable disease. Recently developed targeted therapy gave new hope for the patients with multiple myeloma. Velcade in combination with other agents are currently in trials for the newly diagnosed patient, we designed sequential treatment with VTD and MPT for the patients who are not transplant candidates. This would be expected to result in maximal tumor control, and thus, in maximal survival benefit, equivalent to high dose therapy with autologous transplantation in younger population

Conditions

Multiple Myeloma

Keywords

Multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Response rate of VTD induction Therapy

  2008-02-01

Secondary Outcomes (3)

• Response rate of VTD/MPT maintenance therapy

  2008-02-01

• Progression free survival Overall survival of VTD/MPT

  2008-02-01

• To evaluate toxicities of VTD/MPT

  2008-02-01

Interventions

Velcade DRUG

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Newly diagnosed patients with overt multiple myeloma who are not candidates for HDT/SCT because of old age (\> 65) or presence of comorbid conditions likely to have a negative impact on tolerability of HDT/SCT. Sponsors review this conditions and approval is required.
• Presence of measurable disease : serum M-protein \> 1g/dL or urine M- protein \> 400mg/day
• Performance status £ ECOG 2
• Expected survival ³ 6 months
• Pretreatment clinical laboratory values meeting the following criteria within 14 days before enrollment platelet ≥ 100 x 109/L 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 aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal total bilirubin ≤ 1.5 times the upper limit of normal serum creatinine ≤ 3mg/dL corrected serum calcium \<14 mg/dL (\<3.5 mmol/L)
• Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

You may not qualify if:

• Smoldering or indolent myeloma
• History of allergic reaction attributable to compounds containing boron or mannitol
• Known hypersensitivity to thalidomide or dexamethasone
• Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
• Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction \<0.5 : Severe conduction disorder : Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg
• Sepsis
• Pregnancy or breastfeeding
• Uncontrolled Diabetes Mellitus
• Recurrent DVT or pulmonary embolism
• Active ulcers detected by gastroscopy
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Receipt of extensive radiation therapy within 4 weeks

Sponsors & Collaborators

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

Study Sites (1)

Gachon University Gil Hospital

Inchon, 405-220, South Korea

Location

Related Publications (1)

• Eom HS, Kim YK, Chung JS, Kim K, Kim HJ, Kim HY, Jin JY, Do YR, Oh SJ, Suh C, Seong CM, Kim CS, Lee DS, Lee JH. Bortezomib, thalidomide, dexamethasone induction therapy followed by melphalan, prednisolone, thalidomide consolidation therapy as a first line of treatment for patients with multiple myeloma who are non-transplant candidates: results of the Korean Multiple Myeloma Working Party (KMMWP). Ann Hematol. 2010 May;89(5):489-97. doi: 10.1007/s00277-009-0871-y. Epub 2009 Dec 10.

  PMID: 20012045 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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

• Jae Hoon Lee, M.D.

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

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: April 27, 2006
• First Posted: May 3, 2006
• Study Start: April 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 6, 2008

Record last verified: 2006-04

Locations

KR (1)