Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM) (KMM-97)
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ClinicalTrials.gov Identifier: NCT01114048
Verified September 2011 by Chonnam National University Hospital. Recruitment status was: Recruiting
In this study, the investigators will analyze the long-term outcomes of remission and survival, and identify those with primary resistant disease as more likely to benefit from CTD (thalidomide, cyclophosphamide, dexamethasone) and early intensification of Vel-CD (bortezomib and CD) as induction chemotherapy followed by autologous stem cell transplantation for the patients with newly diagnosed multiple myeloma.
This study aims to assess the efficacy and toxicities of CTD and Vel-CD induction followed by high-dose therapy with autologous stem cell transplantation as a first line treatment for the patients with multiple myeloma.The investigators already investigated the thalidomide-based chemotherapy in patients with newly diagnosed MM. The combined regimen consisted of cyclophosphamide, thalidomide and dexamethasone (CTD) for induction treatment. CTD chemotherapy resulted in a favorable response with 79.4% overall response rate including 42.6% complete response (CR) or very good partial complete response (VGPR), and tolerable toxicity in MM patients. Moreover, CTD chemotherapy did not affect the yield of the stem cell collection.The investigators also published that the clinical efficacy and safety of a four-drug combination of bortezomib, cyclophosphamide, thalidomide, and dexamethasone was assessed for patients with relapsed or refractory multiple myeloma Vel-CTD chemotherapy.
Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM) Who Are Eligible for Autologous Stem Cell Transplantation: Multicenter Phase 2 Study
Study Start Date
Estimated Primary Completion Date
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Induction therapy with CTD regimen for 4 cycles Thalidomide 50-100 mg P.O. HS D 1~28 Cyclophosphamide 150 mg/m² P.O. D 1~4 Dexamethasone 20 mg/ m² IV or P.O. D 1~4, 15-18 Repeated every 28 days
Intensification with Vel-CD regimen for 4 cycles (patients who fail to achieve more than PR after 2 cycles of CTD) Velcade 1.3 mg/m2 IV D1, 4, 8, 11 Cyclophosphamide 150 mg/m² P.O. D 1~4 Dexamethasone 20 mg/ m² IV or P.O. D1, 4, 8, 11 Repeated every 21 days
Bactrim prophylaxis during dexamethasone administration Acyclovir prophylaxis during velcade administration Aspirin medication during thalidomide administration
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Newly diagnosed MM
Aged between 18 and 65 years old
With following measurable lesions (serum M-protein ≥ 1 g/dL or urine M-protein ≥ 400 mg/day, or free light chain ≥ 100 mg/L)
Smoldering or indolent myeloma
ECOG performance status > 3 point
Known hypersensitivity to cyclophosphamide, 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, 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
Impaired hepatic function (AST or ALT ≥ x 3 upper normal, T-bilirubin ≥ x 2 upper normal)
Creatinine clearance < 20 ml/min
Corrected serum calcium ≥ 14 mg/dL
Sepsis or current active infection
Pregnancy or breast feeding
Uncontrolled Diabetes Mellitus
Previous history of 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