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

This study has been completed.
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by:
Korean Multiple Myeloma Working Party
ClinicalTrials.gov Identifier:
NCT00320476
First received: April 27, 2006
Last updated: May 5, 2008
Last verified: April 2006
  Purpose

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


Condition Intervention Phase
Multiple Myeloma
Drug: Velcade
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Korean Multiple Myeloma Working Party:

Primary Outcome Measures:
  • Response rate of VTD induction Therapy [ Time Frame: 2008-02-01 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate of VTD/MPT maintenance therapy [ Time Frame: 2008-02-01 ] [ Designated as safety issue: Yes ]
  • Progression free survival Overall survival of VTD/MPT [ Time Frame: 2008-02-01 ] [ Designated as safety issue: Yes ]
  • To evaluate toxicities of VTD/MPT [ Time Frame: 2008-02-01 ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: April 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320476

Locations
Korea, Republic of
Gachon University Gil Hospital
Inchon, Korea, Republic of, 405-220
Sponsors and Collaborators
Korean Multiple Myeloma Working Party
Janssen-Cilag Ltd.
Investigators
Principal Investigator: Jae Hoon Lee, M.D. Gachon University Gil Hospital
  More Information

No publications provided by Korean Multiple Myeloma Working Party

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lee M.D., korean Multiple Myeloma Working Party
ClinicalTrials.gov Identifier: NCT00320476     History of Changes
Other Study ID Numbers: KMM52, 26866138MMY2027
Study First Received: April 27, 2006
Last Updated: May 5, 2008
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Korean Multiple Myeloma Working Party:
Multiple myeloma

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
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014