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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Velcade
Sponsored by
Korean Multiple Myeloma Working Party
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Gachon University Gil Hospital

Outcomes

Primary Outcome Measures

Response rate of VTD induction Therapy

Secondary Outcome Measures

Response rate of VTD/MPT maintenance therapy
Progression free survival Overall survival of VTD/MPT
To evaluate toxicities of VTD/MPT

Full Information

First Posted
April 27, 2006
Last Updated
May 5, 2008
Sponsor
Korean Multiple Myeloma Working Party
Collaborators
Janssen-Cilag Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00320476
Brief Title
VTD Followed By MPT Maintenance As a First Line Treatment For The Patients With MM Who Are Non-Transplant Candidates
Official Title
Velcade®, Thalidomide, Dexamethasone (VTD) Induction Therapy Followed By Melphalan, Prednisone, Thalidomide (MPT) Maintenance As a First Line Treatment For The Patients With Multiple Myeloma Who Are Non-Transplant Candidates
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korean Multiple Myeloma Working Party
Collaborators
Janssen-Cilag Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
The two effective and non-cross resistant regimens, VTD and MPT, will be applied sequentially to the patients with multiple myeloma 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Velcade
Primary Outcome Measure Information:
Title
Response rate of VTD induction Therapy
Time Frame
2008-02-01
Secondary Outcome Measure Information:
Title
Response rate of VTD/MPT maintenance therapy
Time Frame
2008-02-01
Title
Progression free survival Overall survival of VTD/MPT
Time Frame
2008-02-01
Title
To evaluate toxicities of VTD/MPT
Time Frame
2008-02-01

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Hoon Lee, M.D.
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gachon University Gil Hospital
City
Inchon
ZIP/Postal Code
405-220
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20012045
Citation
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.
Results Reference
derived

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

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