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

Primary Purpose

Multiple Myeloma

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Intravenous busulfan and melphalan

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Autologous transplantation, Multiple Myeloma, Intravenous Busulfan

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Hospital Insular CanariasRecruiting
H La PrincesaRecruiting
H. 12 de OctubreRecruiting
S. de Hematología. Hospital La FeRecruiting
Hospital ClínicoRecruiting
Hospital Dr. PesetRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravenous busulfan and melphalan

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00804947

First Posted

December 5, 2008

Last Updated

December 8, 2008

Sponsor

Fundacion Para La Investigacion Hospital La Fe

1. Study Identification

Unique Protocol Identification Number

NCT00804947

Brief Title

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

Official Title

Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Unknown status

Study Start Date

September 2005 (undefined)

Primary Completion Date

March 2010 (Anticipated)

Study Completion Date

March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Fundacion Para La Investigacion Hospital La Fe

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Primary Efficacy and safety of the procedure in terms of number of remissions, survival, event-free survival, relapse risk, and early transplant-related mortality (up to day +100). Secondary Graft kinetics (time to neutrophil and platelet recovery after ASCT) 2.Analyze the presence of transplant-related complications (infections, sinusoidal occlusive syndrome and others) 3.Analyze prognostic factors for engraftment, remission rate, relapse risk, disease-free and overall survival after ASCT

6. Conditions and Keywords

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

Multiple Myeloma

Keywords

Autologous transplantation, Multiple Myeloma, Intravenous Busulfan

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravenous busulfan and melphalan

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Intravenous busulfan and melphalan

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

Within the first three months after transplant

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to 5 years after transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

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

Javier de la Rubia, MD

Phone

34963862746

delarubia_jav@gva.es

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

Guillermo Sanz, MD

Phone

34963862746

sanz_gui@gva.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miguel A Sanz, MD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Insular Canarias

City

Las Palmas de Gran Canaria

State/Province

Las Palmas

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan D González, MD

jdgonsan@gobiernodecanarias.org

First Name & Middle Initial & Last Name & Degree

Juan D González, MD

Facility Name

H La Princesa

City

Madrid

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adrián Alegre, MD

Adrian.Alegre@telefonica.net

First Name & Middle Initial & Last Name & Degree

Adrián Alegre, MD

Facility Name

H. 12 de Octubre

City

Madrid

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan J Lahuerta, MD

jjlahuerta@terra.es

First Name & Middle Initial & Last Name & Degree

Juan J Lahuerta, MD

Facility Name

S. de Hematología. Hospital La Fe

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Javier de la Rubia, MD

First Name & Middle Initial & Last Name & Degree

Guillermo Sanz, MD

First Name & Middle Initial & Last Name & Degree

Isidro Jarque, MD

Facility Name

Hospital Clínico

City

Valencia

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlos Solano, MD

carlos.solano@uv.es

First Name & Middle Initial & Last Name & Degree

Carlos Solano, MD

Facility Name

Hospital Dr. Peset

City

Valencia

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paz Ribas, MD

ribas_paz@gva.es

First Name & Middle Initial & Last Name & Degree

Paz Ribas, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

22897964

Citation

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.

Results Reference

derived

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

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