Multiple MyelomaPhase 2NCT00804947
Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen
A Phase 2 study testing Intravenous busulfan and melphalan in people with Multiple Myeloma, run by Fundacion Para La Investigacion Hospital La Fe at 6 sites in Spain.
Trial summary
Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Intravenous busulfan and melphalan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesSpain
- Study dates
- Sep 2005to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Insular Canarias
Las Palmas de Gran Canaria, Las Palmas
Juan D González, MD, jdgonsan@gobiernodecanarias.org
Juan D González, MD
- Recruiting
H La Princesa
Madrid, Madrid
Adrián Alegre, MD, Adrian.Alegre@telefonica.net
Adrián Alegre, MD
- Recruiting
H. 12 de Octubre
Madrid, Madrid
Juan J Lahuerta, MD, jjlahuerta@terra.es
Juan J Lahuerta, MD
- Recruiting
S. de Hematología. Hospital La Fe
Valencia, Valencia, 46009
Javier de la Rubia, MD
Guillermo Sanz, MD
- Recruiting
Hospital Clínico
Valencia, Valencia
Carlos Solano, MD, carlos.solano@uv.es
Carlos Solano, MD
- Recruiting
Hospital Dr. Peset
Valencia, Valencia
Paz Ribas, MD, ribas_paz@gva.es
Paz Ribas, MD
About this study
Official title: Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan
Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.
Read the 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
- Conditions
- Multiple Myeloma
- Being tested
- Intravenous busulfan and melphalan
- Keywords
- Autologous transplantation, Multiple Myeloma, Intravenous Busulfan
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous busulfan and melphalanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous busulfan and melphalan | Experimental | Not described Receives: Drug: Intravenous busulfan and melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to analyze the safety profile and determine the overall response rate after ASCT with this conditioning regimen.
Measured: 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
Measured: Up to 5 years after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startSep 2005
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Para La Investigacion Hospital La Fe
- Sponsor type
- University, hospital or other
- Investigators
- Miguel A Sanz, MD, Study director, S: de Hematología. Hospital La Fe, Valencia. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804947
- Sponsor's protocol ID
- BuMel-MM
- Status last verified
- Dec 2008
- First submitted
- 5 Dec 2008
- Last updated
- 9 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22897964
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan
- ClinicalTrials.gov ID
- NCT00804947
- Acronym / sponsor ID
- BuMel-MM
- Conditions
- Multiple Myeloma
- Keywords
- Autologous transplantation, Multiple Myeloma, Intravenous Busulfan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundacion Para La Investigacion Hospital La FeUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous busulfan and melphalan | Experimental | Drug: Intravenous busulfan and melphalan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous busulfan and melphalanBU 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. | Drug | Intravenous busulfan and melphalan |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2008.
- Derived from this study: PubMed 22897964Blanes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel A Sanz, MD study director
S: de Hematología. Hospital La Fe, Valencia. Spain
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous busulfan and melphalan in people with Multiple Myeloma, run by Fundacion Para La Investigacion Hospital La Fe at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier de la Rubia, MD (34963862746, delarubia_jav@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2008.