Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM)

Trial Title: Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM)

NCT ID: NCT01114048

Condition: Multiple Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Thalidomide
Dexamethasone
Cyclophosphamide
Bortezomib

Conditions: Keywords:
age under 65
Previous untreated

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Thalidomide, cyclophosphamide, dexamethasone, bortezomib
Description: 1. 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 2. 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

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Newly diagnosed MM 2. Aged between 18 and 65 years old 3. With following measurable lesions (serum M-protein ≥ 1 g/dL or urine M-protein ≥ 400 mg/day, or free light chain ≥ 100 mg/L) Exclusion Criteria: 1. Smoldering or indolent myeloma 2. ECOG performance status > 3 point 3. Known hypersensitivity to cyclophosphamide, thalidomide or dexamethasone 4. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3 5. 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 6. Impaired hepatic function (AST or ALT ≥ x 3 upper normal, T-bilirubin ≥ x 2 upper normal) 7. Creatinine clearance < 20 ml/min 8. Corrected serum calcium ≥ 14 mg/dL 9. Sepsis or current active infection 10. Pregnancy or breast feeding 11. Uncontrolled Diabetes Mellitus 12. Previous history of Recurrent DVT or pulmonary embolism 13. Active ulcers detected by gastroscopy 14. Serious medical or psychiatric illness likely to interfere with participation in this clinical study. 15. Receipt of extensive radiation therapy within 4 weeks

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Hwasun-gun
Zip: 519-809
Country: Korea, Republic of

Status: Recruiting

Investigator:
Last name: Je-Jung Lee, M.D. and Ph.D.
Email: Principal Investigator

Start date: March 2010

Lead sponsor:
Agency: Chonnam National University Hospital
Agency class: Other

Source: Chonnam National University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01114048