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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320476
• Other study ID #: KMM52
• Secondary ID: 26866138MMY2027
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2006
• Last updated: May 5, 2008
• Start date: April 2006
• Est. completion date: February 2008

Study information

• Verified date: April 2006
• Source: Korean Multiple Myeloma Working Party
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Velcade

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Hospital	Inchon

Sponsors (2)

Lead Sponsor	Collaborator
Korean Multiple Myeloma Working Party	Janssen-Cilag Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of VTD induction Therapy		2008-02-01	Yes
Secondary	Response rate of VTD/MPT maintenance therapy		2008-02-01	Yes
Secondary	Progression free survival Overall survival of VTD/MPT		2008-02-01	Yes
Secondary	To evaluate toxicities of VTD/MPT		2008-02-01	Yes