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

NCT ID: NCT01114048

Last Updated: 2011-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31

Brief 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Thalidomide, cyclophosphamide, dexamethasone, bortezomib

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chonnam National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chonnam National University Hwasun Hospital

Locations

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Je-Jung Lee, M.D. and Ph.D.

Role: CONTACT

drjejung@chonnam.ac.kr

82-61-3797638

Deok-Hwan Yang, M.D. and Ph.D.

Role: CONTACT

drydh1685@gmail.com

82-61-3797636

Other Identifiers

KMM-97

Identifier Type: -

Identifier Source: org_study_id