Status:
COMPLETED
Sequential High-dose Dexamethasone and Response Adopted PAD or VAD Induction Chemotherapy Followed by High-dose Chemotherapy With Autologous Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Yonsei University
Conditions:
Multiple Myeloma
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief Summary
Complete Response (CR) plus near CR rate of VAD (Vincristine, Adriamycin, Dexamethasone) induction chemotherapy followed by ASCT in patients with newly diagnosed MM was about 50% and CR plus near CR r...
Eligibility Criteria
Inclusion
- Patients with a confirmed diagnosis of multiple myeloma (MM)
- Symptomatic MM (multiple myeloma with related organ or tissue damage)
- Previously untreated
- Age 20-65 years
- Performance status: ECOG 0-2
- Patient has measurable disease, defined as follows: For secretory multiple myeloma, measurable disease is defined as any quantifiable serum M-protein value and, where applicable, urine light chain of ≥200 mg/24 hours.
- For oligo-secretory multiple myeloma, measurable disease is defined as quantifiable light chain paraprotein on serum free light chain assay.
- For non-secretory multiple myeloma, measurable disease is defined as presence of soft tissue plasmacytoma(s) as determined by clinical examination or radiographic examination such as CT scan and magnetic resonance imaging (MRI), etc.
- Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormalities
- Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value, Bilirubin \< 2 X upper normal value
- Adequate hematological function: Platelet count ≥ 75 x 109/L, hemoglobin ≥ 8 g/dL, (Prior RBC transfusion or recombinant human erythropoietin use is allowed), absolute neutrophil count (ANC) ≥ 1.0 x 109/L
- A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are \< 1 years after the onset of menopause.
- Informed consent
Exclusion
- Systemic AL amyloidosis, smoldering multiple myeloma or MGUS
- Patient with plasma cell leukemia (\> 20% plasma cells in the PB and an absolute plasma cell count of at least 2000/μL)
- Previous chemotherapy or radiotherapy for the treatment of MM
- Patient is known to be Human Immunodeficiency Virus (HIV) positive
- Patient has known clinically active Hepatitis B or C
- Previous renal transplantation
- Severe peripheral neuropathy (Grade 2 or higher as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0)
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions :
- i. Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis ii. History of significant neurological or psychiatric disorders including dementia or seizures iii. Active uncontrolled infection (viral, bacterial or fungal infection) iv. Other serious medical illnesses
- Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to compounds containing boron or mannitol)
- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
Key Trial Info
Start Date :
October 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01255514
Start Date
October 30 2008
End Date
December 31 2014
Last Update
November 28 2017
Active Locations (8)
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1
National Cancer Center
Goyang, South Korea
2
Chonnam National University Hwasun Hospital
Hwasun, South Korea
3
Gachon University Gill Hospital
Incheon, South Korea
4
Severance Hospital
Seoul, South Korea, 120-752