CancerPhase 1/2NCT00793650
Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study
A Phase 1/2 study testing Bortezomib, Melphalan and Autologous PBSC Transplant in people with Cancer and Multiple Myeloma, run by Emory University at 1 site in United States.
Trial summary
The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Multiple Myeloma
- What is being tested?
- Bortezomib, Melphalan and Autologous PBSC Transplant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Sep 2011
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multiple myeloma who are eligible for an autologous peripheral blood progenitor transplant
- Male and female subjects between the age of 18 and 70 years.
- Patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subjects agrees to use an acceptable method for contraception for the duration of the study.
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- Biopsy proven diagnosis of multiple myeloma from bone marrow aspirate and biopsy prior to study initiation
- Patient has achieved less than 90% disease reduction from previous treatment prior to transplant (as measured by serum or urine protein electrophoresis) and has more than 5% plasma cells in the bone marrow, or patient has progressed and has more than 5% plasma cells in the bone marrow.
- Karnofsky Performance Status score of ≥ 60%
- Patient has met the following laboratory requirements prior to Day -4
- Platelet count ≥ 50, 000/mm3
- Absolute Neutrophil Count ≥ 500/mm3
- Hemoglobin ≥ 10 g/dL (transfusion allowed to meet this criterion)
- Calculated creatinine clearance ≥ 30mL/min
- Toxic effects of previous therapy or surgery resolved to Grade 2 or better
Who cannot join
- Unsupportable anemia with < 10b/dL
- Patient has a calculated or measured creatinine clearance of < 30mL/min within 14 days before enrollment
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment
- Patient has hypersensitivity to bortezomib, boron or mannitol
- Patient has had an allergic reaction to melphalan or chlorambucil
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
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- Patient has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Cardiac or pulmonary dysfunction such that patients do not meet institutional pre-transplant evaluation criteria
- Known central nervous system involvement or suspicion of involvement with Myeloma
- Other active malignancies (with the exception of basal and squamous cell skin cancer) within 5 years of study entry. Patients with treated prostate or cervical cancer in situ who are 2 or more years from therapy and remain free of disease may be entered into the study at the investigator's discretion.
- Known to be HIV positive, HIV-1 positive
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Combination High Dose Melphalan and Autologous PBSC Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study
The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.
- Conditions
- Cancer, Multiple Myeloma
- Being tested
- Bortezomib, Melphalan, Autologous PBSC Transplant
- Keywords
- Cancer, Multiple Myeloma, Peripheral Blood Stem Cell Transplant
- Medical subject headings
- Neoplasms, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Bortezomib or Velcade
Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B.
MelphalanDrug
Also called Bortezomib or Velcade
All patients received melphalan (100 mg/m^2/day × 2; days
-3 and -2), for a total dose of 200 mg/m^2.
Autologous PBSC TransplantProcedure or surgery
Day 0 consists of the stem cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib before Melphalan | Active comparator | Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan. Receives: Drug: Bortezomib; Drug: Melphalan; Procedure: Autologous PBSC Transplant |
| Bortezomib after Melphalan | Active comparator | Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan. Receives: Drug: Bortezomib; Drug: Melphalan; Procedure: Autologous PBSC Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Engraftment
Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.
Measured: Day 30 after transplant
Secondary outcomes (1)
Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.
CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour.
Partial Response:>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200mg per 24 hour.
Measured: 100 days after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startMay 2005
- Primary completionOct 2009
- Study completionSep 2011
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 CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Sagar Lonial, Emory University
- Investigators
- Sagar Lonial, MD, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793650
- Sponsor's protocol ID
- 080-2005
- Status last verified
- Aug 2012
- First submitted
- 17 Nov 2008
- Last updated
- 30 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination High Dose Melphalan and Autologous PBSC Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study
- ClinicalTrials.gov ID
- NCT00793650
- Acronym / sponsor ID
- 080-2005
- Conditions
- Cancer, Multiple Myeloma
- Keywords
- Cancer, Multiple Myeloma, Peripheral Blood Stem Cell Transplant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- May 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Posted 18 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bortezomib before Melphalan | Active comparator | Drug: Bortezomib, Drug: Melphalan, Procedure: Autologous PBSC TransplantEnrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan. |
| Bortezomib after Melphalan | Active comparator | Drug: Bortezomib, Drug: Melphalan, Procedure: Autologous PBSC TransplantEnrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with multiple myeloma who are eligible for an autologous peripheral blood progenitor transplant
- Male and female subjects between the age of 18 and 70 years.
- Patient has given informed consent prior to any study related procedures with the knowledge that consent can be withdrawn at anytime without prejudice to future medical care
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
Key exclusion criteria (12 listed)
- Unsupportable anemia with < 10b/dL
- Patient has a calculated or measured creatinine clearance of < 30mL/min within 14 days before enrollment
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment
- Patient has hypersensitivity to bortezomib, boron or mannitol
- Patient has had an allergic reaction to melphalan or chlorambucil
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 |
|---|---|---|
| BortezomibAlso: Bortezomib or VelcadeEscalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B. | Drug | Bortezomib after Melphalan, Bortezomib before Melphalan |
| MelphalanAlso: Bortezomib or VelcadeAll patients received melphalan (100 mg/m^2/day × 2; days -3 and -2), for a total dose of 200 mg/m^2. | Drug | Bortezomib after Melphalan, Bortezomib before Melphalan |
| Autologous PBSC TransplantDay 0 consists of the stem cell infusion. | Procedure or surgery | Bortezomib after Melphalan, Bortezomib before Melphalan |
Primary outcome
Safety and Engraftment
Time frame: Day 30 after transplant
Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.
1 secondary outcome
Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.
Time frame: 100 days after transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
- 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.
Sagar Lonial, MD principal investigator
Emory University Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bortezomib, Melphalan and Autologous PBSC Transplant in people with Cancer and Multiple Myeloma, run by Emory University 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 15 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: stopped early, as of the sponsor's last update on 30 Aug 2012. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 18 Jun 2012). 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?
Safety and Engraftment (time frame: Day 30 after transplant). 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 30 Aug 2012.