Multiple MyelomaPhase 2NCT00615589
Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
A Phase 2 study testing Fludarabine/Busulfan x 4 days and stem cell transplant in people with Multiple Myeloma and Plasma Cell Leukemia, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem cell transplant - a procedure where the patient is treated with high dose chemotherapy and then their own (autologous) stem cells are transplanted back into their body. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma, Plasma Cell Leukemia
- What is being tested?
- Fludarabine/Busulfan x 4 days and stem cell transplant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Biologic high risk Multiple Myeloma:
- Stage II/III Multiple Myeloma, any of: t(4; 14), t(14; 16),(14:20) by Fish; 17P- by conventional cytogenetics or Fish; ∆13 by conventional cytogenetics; Hypodiploidy by conventional cytogenetics.
- Relapsed or persistent multiple myeloma after ASCT.
- Persistent multiple myeloma, regardless of previous therapies.
- Plasma cell leukemia, regardless of previous therapies.
- Age up to 70 years old (less than 71 years old at the date of transplant admission).
Show all 9Show fewer
- Disease status: in CR, nCR, VGPR, PR or stable disease within 1 month of admission
- Patients with non-secretory and oligosecretory disease are eligible if they meet certain criteria within 2 weeks prior to the transplant.
- Specific renal, liver, cardiac, and pulmonary function requirements(all must be met within 30 days of transplant admission)
Who cannot join
- Persistent invasive infections, not controlled by antimicrobials.
- HIV-1/HIV-2 or HTLV-1/HTLV-2 seropositivity.
- Uncontrolled medical or psychiatric disorder.
- No response or progressive disease at the time of transplantation.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan,Department of Internal Med. Hematology- Oncology
Ann Arbor, Michigan, 48109
About this study
Official title: Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem cell transplant - a procedure where the patient is treated with high dose chemotherapy and then their own (autologous) stem cells are transplanted back into their body. Patients with multiple myeloma and high risk genes, always relapse after an autologous transplant and often die within two years from the time of their transplant. A different type of transplant allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the donor cells may help kill the lymphoid cancer cells.
This study will investigate if a matched donor stem cell transplant using a newer, reduced toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple Myeloma.
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Being tested
- Fludarabine/Busulfan x 4 days, stem cell transplant
- Keywords
- Stage II/III Multiple Myeloma(within 10 months from diagnosis), high risk, relapse, persistent
- Medical subject headings
- Multiple Myeloma, Leukemia, Plasma Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludarabine/Busulfan x 4 daysDrug
- Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant.
- Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2.
The Fludarabine shall be administered prior to the Busulfan each day.
stem cell transplantProcedure or surgery
Allogeneic, peripheral blood stem cell transplant
| Study group | Role | What they receive |
|---|---|---|
| Flu-Bu4 | Experimental | Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Receives: Drug: Fludarabine/Busulfan x 4 days; Procedure: stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients Alive 1 Year Post Transplant
The primary objective is overall survival, one year from the time of transplant.
Measured: 1 Year
Secondary outcomes (4)
The Percentage of Patients Free From Progression at 1 Year
One of the secondary outcomes that will be measured is progression free survival at 1 Year.
Progressive Disease (PD) is defined as a >25% increase in serum monoclonal paraprotein, a >25% increase in 24-hour urinary light chain excretion, a >25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.
Measured: 1 Year
Percentage of Patients With Treatment Related Mortality (TRM)
Measured: 100 days, one-year
Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)
Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed.
Acute GVHD Grading:
Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, >1500ml/day diarrhea Stage IV - Skin, bullae; Liver, >15mg/dl bilirubin; Gut, pain +/- ileus
Measured: 100 days, 2 years
Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression
Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2012
- Study completionJan 2013
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Attaphol Pawarode, MD, Principal investigator, University of Michigan Dept. of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615589
- Sponsor's protocol ID
- umcc 2007.074
- Other IDs
- HUM00014029
- Status last verified
- Mar 2016
- First submitted
- 22 Jan 2008
- Last updated
- 4 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Hematopoietic Stem Cell Transplantation For The Treatment Of High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
- ClinicalTrials.gov ID
- NCT00615589
- Acronym / sponsor ID
- umcc 2007.074
- Conditions
- Multiple Myeloma, Plasma Cell Leukemia
- Keywords
- Stage II/III Multiple Myeloma(within 10 months from diagnosis), high risk, relapse, persistent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- Feb 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Posted 11 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Standard therapy for multiple myeloma (MM) usually includes an autologous bone marrow stem cell transplant - a procedure where the patient is treated with high dose chemotherapy and then their own (autologous) stem cells are transplanted back into their body. Patients with multiple myeloma and high risk genes, always relapse after an autologous transplant and often die within two years from the time of their transplant. A different type of transplant allogeneic) using donor cells, may work better for high-risk Multiple Myeloma, because the donor cells may help kill the lymphoid cancer cells.
This study will investigate if a matched donor stem cell transplant using a newer, reduced toxicity, chemotherapy (Flu-Bu4) is a feasible option for patients with high risk, Multiple Myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flu-Bu4 | Experimental | Drug: Fludarabine/Busulfan x 4 days, Procedure: stem cell transplantFludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biologic high risk Multiple Myeloma:
- Age up to 70 years old (less than 71 years old at the date of transplant admission).
- Disease status: in CR, nCR, VGPR, PR or stable disease within 1 month of admission
- Patients with non-secretory and oligosecretory disease are eligible if they meet certain criteria within 2 weeks prior to the transplant.
- Specific renal, liver, cardiac, and pulmonary function requirements(all must be met within 30 days of transplant admission)
Key exclusion criteria (5 listed)
- Persistent invasive infections, not controlled by antimicrobials.
- HIV-1/HIV-2 or HTLV-1/HTLV-2 seropositivity.
- Uncontrolled medical or psychiatric disorder.
- No response or progressive disease at the time of transplantation.
- Pregnancy
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 |
|---|---|---|
| Fludarabine/Busulfan x 4 days* Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. * Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day. | Drug | Flu-Bu4 |
| stem cell transplantAllogeneic, peripheral blood stem cell transplant | Procedure or surgery | Flu-Bu4 |
Primary outcome
The Percentage of Patients Alive 1 Year Post Transplant
Time frame: 1 Year
The primary objective is overall survival, one year from the time of transplant.
4 secondary outcomes
The Percentage of Patients Free From Progression at 1 Year
Time frame: 1 Year
Percentage of Patients With Treatment Related Mortality (TRM)
Time frame: 100 days, one-year
Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)
Time frame: 100 days, 2 years
Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Attaphol Pawarode, MD principal investigator
University of Michigan Dept. of Internal Medicine
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 Fludarabine/Busulfan x 4 days and stem cell transplant in people with Multiple Myeloma and Plasma Cell Leukemia, run by University of Michigan Rogel Cancer Center at 1 site in United States.
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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Apr 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Patients Alive 1 Year Post Transplant (time frame: 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 4 Apr 2016.