Back to results

Early Response-adapted Intensification of Induction Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (MM) (KMM-97)

Primary Purpose

Multiple Myeloma

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Thalidomide, cyclophosphamide, dexamethasone, bortezomib

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring age under 65, Previous untreated

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Chonnam National University Hwasun HospitalRecruiting

Outcomes

Primary Outcome Measures

response rate for induction chemotherapy

Secondary Outcome Measures

Full Information

NCT ID

NCT01114048

First Posted

April 28, 2010

Last Updated

September 21, 2011

Sponsor

Chonnam National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01114048

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Unknown status

Study Start Date

March 2010 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Chonnam National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

age under 65, Previous untreated

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Thalidomide, cyclophosphamide, dexamethasone, bortezomib

Intervention Description

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

Primary Outcome Measure Information:

Title

response rate for induction chemotherapy

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

82-61-3797638

drjejung@chonnam.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

82-61-3797636

drydh1685@gmail.com

Facility Information:

Facility Name

Chonnam National University Hwasun Hospital

City

Hwasun-gun

State/Province

Jeollanam-do

ZIP/Postal Code

519-809

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs