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

Korean Multiple Myeloma Working Party

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Velcade

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00320476

26866138MMY2027

KMM52

Details and patient eligibility

About

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

Full 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

Enrollment

35 patients

Sex

All

Ages

65 to 75 years old

Volunteers

No 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