Busulfan and Melphalan Conditioning in Multiple Myeloma

NCT01923935 | Unknown Phase 2 DMC

• 1 other identifier: KFDA20120110139
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 8

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.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma, busulfan, melphalan,transplantation

Outcome Measures

Primary Outcomes (2)

• Treatment response up to 2 months after ASCT

  1. To evaluate the objective responses after ASCT, the guidelines from the International Myeloma Working (IMW) Group uniform response criteria will be used. 2. Serum free light chain study will be added at the every evaluation of response. 3. 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)

  2 months later after last patent received ASCT

• 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.

  2 months later after last patent received ASCT

Secondary Outcomes (2)

• Progression free survival(PFS)

  2 months later after last patient received ASCT

• Overall survival (OS)

  2 months later after last patient received ASCT

Study Arms (1)

BUSULFEX®, Alkeran®

EXPERIMENTAL

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)

Drug: BUSULFEX®; Drug: Alkeran®

Interventions

BUSULFEX® DRUG

BUSULFEX® 3.2 mg/kg/day iv once daily over 3 hours (day-6\~day-4)

BUSULFEX®, Alkeran®

Alkeran® DRUG

Alkeran® 70 mg/m2/day iv once daily over 30 minutes (day-3\~day-2)

BUSULFEX®, Alkeran®

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Korea Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (8)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

Gachon University Gil Hospital

Namdong-gu, Incheon, 405-760, South Korea

NOT YET RECRUITING

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, 519-763, South Korea

RECRUITING

Samsung Medical Center

Gangnam-gu, Seoul, 135-710, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Jongno-gu, Seoul, 110-744, South Korea

NOT YET RECRUITING

Ewha Womans University Mokdong Hospital

Mokdong, Seoul, 158-710, South Korea

NOT YET RECRUITING

Seoul St. Mary's hospital

Seocho-gu, Seoul, 137-701, South Korea

NOT YET RECRUITING

Severance Hospital

Seodaemun-gu, Seoul, 120-752, South Korea

NOT YET RECRUITING

Related Publications (32)

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  PMID: 29339269 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Busulfan; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Je-Jung Lee, M.D., Ph.D.

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Je-Jung Lee, M.D., PH.D.

CONTACT

82-61-379-7638; f0115@chonnam.ac.kr

Deok-Hwan Yang, M.D., PH.D.

CONTACT

82-61-379-7636; drydh@chonnam.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 16, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: December 1, 2015
• Last Updated: August 19, 2013

Record last verified: 2013-08

Locations

KR (8)