Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00802568
Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to Treatment
A Phase 2 study testing anti-thymocyte globulin, busulfan and fludarabine phosphate in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- anti-thymocyte globulin, busulfan and fludarabine phosphate
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to May 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma, meeting 1 of the following criteria:
- Stage I disease with a bone lesion
- Stage II or III disease meeting any of the following criteria:
- Elevated beta-2 microglobulin
- Deletion of chromosome 13
- Refractory or relapsed disease
- Presence of an evaluable monoclonal component
- Must have achieved reduction of primary tumor after receiving prior intensified chemotherapy with high-dose melphalan and cyclosporine with autologous transplantation
- HLA identical family donor available
- Bone marrow transplantation is allowed in case hematopoietic stem cell collection fails
PATIENT CHARACTERISTICS:
- Karnofsky 70-100%
- No contraindications to allogeneic transplantation
- No contraindications to drugs used in conditioning regimen
- No psychiatric illness
- No other cancer within the past 5 years except basal cell skin cancer or epithelioma in situ of the cervix
- No serious and uncontrolled infection
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 1 month since participation in another prior clinical trial
Trial locations and contacts
1 site in 1 country.
France1 site
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273
About this study
Official title: Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with multiple myeloma that has not responded to treatment.
Read the detailed description
OBJECTIVES:
Primary
- To study the toxicity of reduced intensity conditioning comprising fludarabine phosphate, busulfan, and anti-thymocyte globulin followed by allogeneic hematopoietic stem cell transplantation in patients with refractory or relapsed multiple myeloma.
Secondary
- To study the tumor response in these patients.
- To study the incidence of acute or chronic graft-versus-host disease in these patients.
- To study the incidence of infectious complications in these patients.
- To study relapse- or progression-free and overall survival of these patients.
- To study the biological mechanisms (i.e., taking graft, immunological recovery, antitumor activity, and chimerism).
OUTLINE: This is a multicenter study.
Patients receive reduced intensity conditioning comprising fludarabine IV on days -5 to -1, oral busulfan on days -4 and -3, and anti-thymocyte globulin IV on days -2 and -1. Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
After completion of study therapy, patients are followed every month for 6 months and then every 3 months for 1½ years.
- Being tested
- anti-thymocyte globulin, busulfan, fludarabine phosphate, allogeneic bone marrow transplantation, nonmyeloablative allogeneic hematopoietic stem cell transplantation
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, osteolytic lesions of multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinBiological
busulfanDrug
allogeneic bone marrow transplantationProcedure or surgery
nonmyeloablative allogeneic hematopoietic stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startApr 2007
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Investigators
- Didier Blaise, MD, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802568
- Sponsor's protocol ID
- CDR0000626720
- Other IDs
- IPC-2005-002, IPC-ITT 04-02, EUDRACT-2005-01053-13, INCA-RECF0428, AMGEN-IPC-2005-002, JANSSEN-IPC-2005-002
- Status last verified
- Dec 2008
- First submitted
- 4 Dec 2008
- Last updated
- 16 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00802568
- Acronym / sponsor ID
- CDR0000626720
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, osteolytic lesions of multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- May 2011 (actual)
- First posted
- 5 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.
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with multiple myeloma that has not responded to treatment.
Detailed description
OBJECTIVES:
Primary
- To study the toxicity of reduced intensity conditioning comprising fludarabine phosphate, busulfan, and anti-thymocyte globulin followed by allogeneic hematopoietic stem cell transplantation in patients with refractory or relapsed multiple myeloma.
Secondary
- To study the tumor response in these patients.
- To study the incidence of acute or chronic graft-versus-host disease in these patients.
- To study the incidence of infectious complications in these patients.
- To study relapse- or progression-free and overall survival of these patients.
- To study the biological mechanisms (i.e., taking graft, immunological recovery, antitumor activity, and chimerism).
OUTLINE: This is a multicenter study.
Patients receive reduced intensity conditioning comprising fludarabine IV on days -5 to -1, oral busulfan on days -4 and -3, and anti-thymocyte globulin IV on days -2 and -1. Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
After completion of study therapy, patients are followed every month for 6 months and then every 3 months for 1½ years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| anti-thymocyte globulin | Biological | – |
| busulfan | Drug | – |
| fludarabine phosphate | Drug | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure or surgery | – |
Primary outcome
Mortality rate at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
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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.
Didier Blaise, MD
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-thymocyte globulin, busulfan and fludarabine phosphate in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate at 1 year. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2011.