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

Multiple Myeloma Clinical Trial

— KMM-97  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01114048
• Other study ID #: KMM-97
• Status: Recruiting
• Phase: Phase 2
• First received: April 28, 2010
• Last updated: September 21, 2011
• Start date: March 2010

Study information

• Verified date: September 2011
• Source: Chonnam National University Hospital
• Contact: Je-Jung Lee, M.D. and Ph.D.
• Phone: 82-61-3797638
• Email: drjejung[@]chonnam.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Thalidomide, cyclophosphamide, dexamethasone, bortezomib
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

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-gun	Jeollanam-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate for induction chemotherapy		2 years	Yes