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Busulfan and Melphalan Conditioning in Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BUSULFEX®
Alkeran®
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, busulfan, melphalan,transplantation

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with a confirmed diagnosis of MM
  • Symptomatic MM
  • Age 20 - 65 years
  • The MM patients who performed the stem cell collection with appropriate stem cell counts, cluster of differentiation 34 positive cells more than 2 x 10^6 /kg
  • Eastern Cooperative Oncology Group 0 - 2
  • The MM patients who received induction chemotherapy regardless of types of induction
  • Patient has measurable disease when the patients started the primary induction therapy, defined as follows: Measurable disease is defined as serum M-protein more than 1 g/dL, urine M-protein more than 200 mg/24 hours, or free light chain more than 100 mg/L
  • Adequate liver functions before ASCT Transaminase less than 3 x upper normal value Bilirubin less than 2 x upper normal value
  • Adequate hematological function - Platelet count more than 50,000 /microliter, hemoglobin more than 8 g / dL but, Prior red blood cell transfusion or recombinant human erythropoietin use is allowed, absolute neutrophil count more than 1,000 / microliter
  • Expected survival: 6 months or more
  • Informed consent

Exclusion Criteria:

  • Systemic amyloid light chain amyloidosis, smoldering multiple myeloma or monoclonal gammopathy of undetermined significance
  • Patient with plasma cell leukemia
  • Patients who received an extensive radiation therapy within 4 weeks
  • Patient is known to be Human Immunodeficiency Virus positive
  • Patient has known clinically active Hepatitis B or C
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • Other serious illness or medical conditions Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis History of significant neurological or psychiatric disorders including dementia or seizures Active uncontrolled infection Active ulcers detected at gastroscopy Other serious medical illnesses
  • Known hypersensitivity to any of the study drugs or its ingredients concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

Sites / Locations

  • National Cancer CenterRecruiting
  • Gachon University Gil Hospital
  • Chonnam National University Hwasun HospitalRecruiting
  • Samsung Medical Center
  • Seoul National University Hospital
  • Ewha Womans University Mokdong Hospital
  • Seoul St. Mary's hospital
  • Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BUSULFEX®, Alkeran®

Arm Description

BUSULFEX® 3.2 mg/kg/day iv once daily over 3 hours (day-6~day-4) Alkeran® 70 mg/m2/day iv once daily over 30 minutes (day-3~day-2)

Outcomes

Primary Outcome Measures

Treatment response up to 2 months after ASCT
To evaluate the objective responses after ASCT, the guidelines from the International Myeloma Working (IMW) Group uniform response criteria will be used. Serum free light chain study will be added at the every evaluation of response. To confirm the stringent complete response (sCR) after ASCT, flow cytometry or immunohistochemistry will be used Response Criteria for Multiple Myeloma: the guidelines from the IMW Group uniform response criteria + Add for criteria of near CR (Immunofixation positive CR)
Safety and toxicity (frequency of grade 3 or worse toxicities) of the conditioning regimen
NCI Common Toxicity Criteria for Adverse Effects version 4.0 will be used for the examination of toxicities.

Secondary Outcome Measures

Progression free survival(PFS)
PFS will be defined from the time of ASCT to the time of first sign of disease progression or death.
Overall survival (OS)
OS will be defined as the period from the time of ASCT to the date of the last follow-up or death from any cause.

Full Information

First Posted
August 9, 2013
Last Updated
August 15, 2013
Sponsor
Chonnam National University Hospital
Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01923935
Brief Title
Busulfan and Melphalan Conditioning in Multiple Myeloma
Official Title
A Phase 2, Open-label, Prospective, Multicenter Study to Evaluate the Efficacy of Intravenous Busulfan and Melphalan as a Conditioning Regimen in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether intravenous busulfan and melphalan as a conditioning regimen is effective in the treatment of multiple myeloma undergoing autologous stem cell transplantation.
Detailed Description
Title A phase 2, open-label, prospective, multicenter study to evaluate the efficacy of intravenous busulfan and melphalan as a conditioning regimen in patients with multiple myeloma (MM) undergoing autologous stem cell transplantation (ASCT) Principal Investigator Je-Jung Lee (Chonnam National University Hwasun Hospital) Co-investigators Hyeon Seok Eom (National Cancer Center) Kihyun Kim (Samsung Medical Center) Chang Ki Min (Seoul St. Mary's Hospital) Soo Jung Kim (Severance Hospital) Sung Soo Yoon (Seoul National University Hospital) Jae Hoon Lee (Gachon University Gil Hospital) Yeung-Chul Mun (Ewha Womans University Mokdong Hospital) Duration 2 years Study phase Phase II Patients Patients with multiple myeloma who undergo autologous stem cell transplantation Objectives(end points) Primary objective: Treatment response up to 2 months after ASCT Safety and toxicity (frequency of grade 3 or worse toxicities) of the conditioning regimen Secondary objective: Progression free survival (PFS) Overall survival (OS) Total patients Initial 105 evaluable patients Complete Response (CR) rate of 200mg/m2 melphalan conditioning chemotherapy followed by ASCT in patients with newly diagnosed MM was about 26% and CR rate of busulfan and melphalan conditioning chemotherapy followed by ASCT in patients with newly diagnosed MM was about 40%. If the CR rate of busulfan and melphalan conditioning chemotherapy followed by ASCT is more than 40%, this combination will be accepted as active conditioning regimen that may be worth for investigating in phase III trial. But, if the CR rate of this regimen is lower than 26%, this has not a merit than 200mg/m2 melphalan conditioning chemotherapy. Based upon the above assumption, this trial was designed by using Simon's optimal two-stage testing procedure. Assuming a target level of interest, p1=0.4, and a lower activity level, p0=0.26 and drop rate 0.1. Initially 44 patients will be accrued. If 13 or more CR rate were observed, the trial will be continued. Accrual will be planned to a total of 105 patients, If total 35 or more patients were assessed as CR, busulfan and melphalan conditioning regimen will be accepted as active regimen, This design provides probability ≤ 0.05 of accepting drugs worse than p0 and probability ≤ 0.20 of rejecting drugs better than p1.if we assume that drop-out rate is 10%, total accrual patient will be 105 Treatment Schedule Busulfan 3.2 mg/kg/day iv once daily over 3 hours(day-6 ~ day-4) Melphalan 70 mg/m2/day iv once daily over 30 minutes(day-3 ~ day-1). If Creatinine Clearance (mL/min) < 50, reduce to 50 mg/m2. If Creatinine Clearance (mL/min) < 30, excluded from the this trial Informed consent Written informed consent must be obtained before any study-specific screening procedures are performed Screening Baseline assessments should be made within 28 days before treatment start: Demographic data (date of birth and sex) Eastern Cooperative Oncology Group performance status Vital signs and physical examination (including height, and weight) Medical history (including previous diseases/treatments and concomitant diseases/ treatments) Hematology - complete blood counts with differential count examination Serum electrolytes (Na, K, Cl, Ca, phosphorus) Serum lactate dehydrogenase Hepatitis B virus/hepatitis C virus/HIV serology (If serologic tests were conducted within 6 months prior to screening, retests are not required) Serum Beta2-microglobulin Quantitative serum M-protein (Serum protein electrophoresis), including immunofixation or immune electrophoresis Quantitative urine M-protein in 24 hrs urine (Urine protein electrophoresis), including immunofixation or immune electrophoresis Serum free light chain assay Creatinine clearance if increased serum creatinine ECG multigated radionuclide angiography or 2D ECHO Chest X-ray, Radiographic skeletal survey including skull, pelvis, vertebral column and long bones Bone marrow aspiration and biopsy with chromosome study, and flow cytometry or immunohistochemistry Assessment Primary outcome measure To evaluate the objective responses after ASCT, the guidelines from the International Myeloma Working (IMW) Group uniform response criteria will be used Response Criteria for Multiple Myeloma the guidelines from the IMW Group uniform response criteria + Add for criteria of near CR (Immunofixation positive CR) Serum free light chain study will be added at the every evaluation of response To confirm the stringent complete response (sCR) after ASCT, flow cytometry or immunohistochemistry will be used NCI Common Toxicity Criteria for Adverse Effects version 4.0 will be used for the examination of toxicities Secondary outcome measure PFS will be defined from the time of ASCT to the time of first sign of disease progression or death OS will be defined as the period from the time of ASCT to the date of the last follow-up or death from any cause

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma, busulfan, melphalan,transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BUSULFEX®, Alkeran®
Arm Type
Experimental
Arm Description
BUSULFEX® 3.2 mg/kg/day iv once daily over 3 hours (day-6~day-4) Alkeran® 70 mg/m2/day iv once daily over 30 minutes (day-3~day-2)
Intervention Type
Drug
Intervention Name(s)
BUSULFEX®
Intervention Description
BUSULFEX® 3.2 mg/kg/day iv once daily over 3 hours (day-6~day-4)
Intervention Type
Drug
Intervention Name(s)
Alkeran®
Intervention Description
Alkeran® 70 mg/m2/day iv once daily over 30 minutes (day-3~day-2)
Primary Outcome Measure Information:
Title
Treatment response up to 2 months after ASCT
Description
To evaluate the objective responses after ASCT, the guidelines from the International Myeloma Working (IMW) Group uniform response criteria will be used. Serum free light chain study will be added at the every evaluation of response. To confirm the stringent complete response (sCR) after ASCT, flow cytometry or immunohistochemistry will be used Response Criteria for Multiple Myeloma: the guidelines from the IMW Group uniform response criteria + Add for criteria of near CR (Immunofixation positive CR)
Time Frame
2 months later after last patent received ASCT
Title
Safety and toxicity (frequency of grade 3 or worse toxicities) of the conditioning regimen
Description
NCI Common Toxicity Criteria for Adverse Effects version 4.0 will be used for the examination of toxicities.
Time Frame
2 months later after last patent received ASCT
Secondary Outcome Measure Information:
Title
Progression free survival(PFS)
Description
PFS will be defined from the time of ASCT to the time of first sign of disease progression or death.
Time Frame
2 months later after last patient received ASCT
Title
Overall survival (OS)
Description
OS will be defined as the period from the time of ASCT to the date of the last follow-up or death from any cause.
Time Frame
2 months later after last patient received ASCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a confirmed diagnosis of MM Symptomatic MM Age 20 - 65 years The MM patients who performed the stem cell collection with appropriate stem cell counts, cluster of differentiation 34 positive cells more than 2 x 10^6 /kg Eastern Cooperative Oncology Group 0 - 2 The MM patients who received induction chemotherapy regardless of types of induction Patient has measurable disease when the patients started the primary induction therapy, defined as follows: Measurable disease is defined as serum M-protein more than 1 g/dL, urine M-protein more than 200 mg/24 hours, or free light chain more than 100 mg/L Adequate liver functions before ASCT Transaminase less than 3 x upper normal value Bilirubin less than 2 x upper normal value Adequate hematological function - Platelet count more than 50,000 /microliter, hemoglobin more than 8 g / dL but, Prior red blood cell transfusion or recombinant human erythropoietin use is allowed, absolute neutrophil count more than 1,000 / microliter Expected survival: 6 months or more Informed consent Exclusion Criteria: Systemic amyloid light chain amyloidosis, smoldering multiple myeloma or monoclonal gammopathy of undetermined significance Patient with plasma cell leukemia Patients who received an extensive radiation therapy within 4 weeks Patient is known to be Human Immunodeficiency Virus positive Patient has known clinically active Hepatitis B or C Pregnant or lactating women, women of childbearing potential not employing adequate contraception Other serious illness or medical conditions Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis History of significant neurological or psychiatric disorders including dementia or seizures Active uncontrolled infection Active ulcers detected at gastroscopy Other serious medical illnesses Known hypersensitivity to any of the study drugs or its ingredients concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Je-Jung Lee, M.D., PH.D.
Phone
82-61-379-7638
Email
f0115@chonnam.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Deok-Hwan Yang, M.D., PH.D.
Phone
82-61-379-7636
Email
drydh@chonnam.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Je-Jung Lee, M.D., Ph.D.
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyeon Seok Eom, M.D., Ph.D.
Phone
82-31-920-2402
Email
hseom@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Hyeon Seok Eom, M.D., Ph.D.
Facility Name
Gachon University Gil Hospital
City
Namdong-gu
State/Province
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Hoon Lee, M.D., Ph.D.
Phone
82-32-460-2186
Email
jhlee@gilhospital.com
First Name & Middle Initial & Last Name & Degree
Jae Hoon Lee, M.D., Ph.D.
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-gun
State/Province
Jeollanam-do
ZIP/Postal Code
519-763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Je-Jung Lee, M.D, Ph.D.
Phone
82-61-379-7638
Email
f0115@chonnam.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae-Sook Ahn, M.D, Ph.D.
Phone
82-61-379-7635
Email
ahnjaesook@hanmail.net
First Name & Middle Initial & Last Name & Degree
Je-Jung Lee, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Deok-Hwan Yang, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Jae-Sook Ahn, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Sung-Hoon Jung, M.D.
Facility Name
Samsung Medical Center
City
Gangnam-gu
State/Province
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kihyun Kim, M.D., Ph.D.
Phone
82-2-3410-3459
Email
kihyunk@skku.edu
First Name & Middle Initial & Last Name & Degree
Kihyun Kim, M.D., Ph.D.
Facility Name
Seoul National University Hospital
City
Jongno-gu
State/Province
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Soo Yoon, M.D., Ph.D.
Phone
82-2-2072-3079
Email
ssysmc@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Sung Soo Yoon, M.D., Ph.D.
Facility Name
Ewha Womans University Mokdong Hospital
City
Mokdong
State/Province
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeung-Chul Mun, M.D., Ph.D.
Phone
82-2-2650-2777
Email
yeungchul@ewha.ac.kr
First Name & Middle Initial & Last Name & Degree
Yeung-Chul Mun, M.D., Ph.D.
Facility Name
Seoul St. Mary's hospital
City
Seocho-gu
State/Province
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Ki Min, M.D., Ph.D.
Phone
82-2-2258-6053
Email
ckmin@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Chang Ki Min, M.D., Ph.D.
Facility Name
Severance Hospital
City
Seodaemun-gu
State/Province
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Jung Kim, M.D.
Phone
82-2-2228-5487
Email
ALVIN97@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Soo Jung Kim, M.D., Ph.D.

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Busulfan and Melphalan Conditioning in Multiple Myeloma

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