Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen

NCT00804947 | Unknown Phase 2

• 1 other identifier: BuMel-MM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.

Conditions

Multiple Myeloma

Keywords

Autologous transplantation; Multiple Myeloma; Intravenous Busulfan

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to analyze the safety profile and determine the overall response rate after ASCT with this conditioning regimen.

  Within the first three months after transplant

Secondary Outcomes (1)

• Evaluate the complete response (CR) rate, the duration of the response, time to progression, event-free and overall survival

  Up to 5 years after transplant

Study Arms (1)

Intravenous busulfan and melphalan

EXPERIMENTAL

Drug: Intravenous busulfan and melphalan

Interventions

Intravenous busulfan and melphalan DRUG

BU is administered intravenously at a dose of 3.2 mg/kg over three hours once a day on days -5 to -3 (total dose 9.6 mg/kg), followed by MEL at a dose of 140 mg/m2 on day -2. After one day of rest, progenitor cells are infused on day 0.

Intravenous busulfan and melphalan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic multiple myeloma
• Male or female subject age \>= 70 years
• The subject has received at least one previous line of therapy including:
• Front-line treatment with VBMCP/VBAD or VAD or second-line therapy with regimens including bortezomib, thalidomide or lenalidomide
• The subject has given voluntary written informed consent

You may not qualify if:

• Use of bortezomib, thalidomide or lenalidomide as front-line therapy
• ECOG satus \>=2
• Left ventricular ejection fraction \<40%
• DLCO and FVC \<39% theoretical value
• Abnormal liver function(total bilirubin \> 2 mg/dL and/or ALT or AST \> 3 x ULN)
• Serum creatinine at transplant \>1.6 mg/dL and/or creatinine clearance \< 65 mL/minute
• Subject has an active systemic infection requiring treatment
• Subject had a myocardial infarction within 6 months of enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrythmias
• Subject has any other serious medical condition (severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease) or psychiatric illness that could potentially interfere with the completion of treatment of this protocol
• Subject is known to be immunodeficiency virus (HIV)-positive
• Subject has received an experimental drug or used and experimental medical device within 4 weeks before enrollment
• If female, the subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative pregnancy test at screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women

Sponsors & Collaborators

• Fundacion Para La Investigacion Hospital La Fe: lead

Study Sites (6)

Hospital Insular Canarias

Las Palmas de Gran Canaria, Las Palmas, Spain

RECRUITING

H La Princesa

Madrid, Madrid, Spain

RECRUITING

H. 12 de Octubre

Madrid, Madrid, Spain

RECRUITING

S. de Hematología. Hospital La Fe

Valencia, Valencia, 46009, Spain

RECRUITING

Hospital Clínico

Valencia, Valencia, Spain

RECRUITING

Hospital Dr. Peset

Valencia, Valencia, Spain

RECRUITING

Related Publications (1)

• Blanes M, Lahuerta JJ, Gonzalez JD, Ribas P, Solano C, Alegre A, Blade J, San Miguel JF, Sanz MA, de la Rubia J. Intravenous busulfan and melphalan as a conditioning regimen for autologous stem cell transplantation in patients with newly diagnosed multiple myeloma: a matched comparison to a melphalan-only approach. Biol Blood Marrow Transplant. 2013 Jan;19(1):69-74. doi: 10.1016/j.bbmt.2012.08.009. Epub 2012 Aug 13.

  PMID: 22897964 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

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)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Miguel A Sanz, MD

  S: de Hematología. Hospital La Fe, Valencia. Spain

  STUDY DIRECTOR

Central Study Contacts

Javier de la Rubia, MD

CONTACT

34963862746; delarubia_jav@gva.es

Guillermo Sanz, MD

CONTACT

34963862746; sanz_gui@gva.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 9, 2008
• Study Start: September 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 9, 2008

Record last verified: 2008-12

Locations

ES (6)