Multiple MyelomaPhase 2NCT00968396
Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts
A Phase 2 study testing Apheresis, Stem Cell Transplantation and Melphalan in people with Multiple Myeloma, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if cleaning the stem cells of a patient who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product capable of replacing the bone marrow after standard treatment with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Apheresis, Stem Cell Transplantation and Melphalan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Feb 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multiple myeloma who have relapsed after an autologous transplant or with a chemosensitive relapse more than one year post initial therapy
- Age 18 to 75 years
- Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias
- FEV1, FVC and DLCO >/= 40%. No symptomatic pulmonary disease
- Serum bilirubin </= 2 x upper limit of normal, SGPT </= 4 x upper limit of normal
- HIV-negative
Show all 9Show fewer
- Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
- Patient or guardian able to sign informed consent
- Marrow-MSC Donor Requirements: patients must have a family member who is matched at 2, 3, or 4 HLA antigens and willing to donate 80-100 ml or bone marrow for MSC generation
Who cannot join
- International Staging System (ISS) stage I at diagnosis (beta-2 microglobulin < 3.5 mg/L and albumin >/= 3.5 g/dL)
- Patients with an apheresis collection </= 7 x 10e6 CD34+/Kg
- A fully matched related donor
About this study
The goal of this clinical research study is to learn if cleaning the stem cells of a patient who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product capable of replacing the bone marrow after standard treatment with chemotherapy.
Read the detailed description
A transplant of one's own bone marrow stem cells is part of a standard treatment for MM. Because MM comes from the bone marrow, stem-cell products from the bone marrow can have tumor cells mixed in them when they are transplanted. This may cause the disease to return after transplant. This study will learn about a method of cleaning, or "purging," the MM tumor cells from the stem cells by using the bone marrow of a relative.
Study Drugs:
Melphalan is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be given G-CSF twice a day through a needle under the skin on Days 1-5 to move stem cells from out of the bone marrow and into the blood.
You will receive melphalan through a needle in your vein over 30 minutes each time on the 2 days directly before you receive the stem cell transplant.
Stem Cell Collection, Purging, and Transplantation:
On Day 5, stem cell collection will begin. You will have a central venous catheter (CVC - a sterile, flexible tube) placed into a vein in your chest while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
Blood will be removed from your body through the CVC and passed through a machine that separates stem cells from the other cells. The stem cells will be frozen for storage, and the blood will be returned to your body. This 3-hour process is called apheresis. This process will be done 1 time a day for 1-6 days, or until enough stem cells are collected.
Your stem cells will be placed in a sterile container, where they will grow and multiply with donated stem cells from a relative. If there are enough cells after 2 weeks, the cells will be transplanted back into the body. If there are not enough cells after the 2 weeks of growing with the donor's stem cells, they will be combined with a sample that was set aside at your initial collection and then transplanted back into the body.
Study Visits:
One (1), 2, and 6 months after the transplant, blood (about 2 teaspoons) will be drawn for routine tests and to check the status of the disease.
Six (6) months after the transplant, you will also have a bone marrow aspirate/biopsy to check the status of the disease.
Length of Study:
You will remain on study until 12 months after the transplant. You will be taken off study if the disease gets worse or needs further treatment.
End-of-Treatment Visit:
Twelve (12) months after the transplant, you will have your end-of-treatment visit. At this time, the following tests and procedures will be performed:
- Blood (about 2 teaspoons) will be drawn for routine tests and to check the status of the disease.
- You will have a bone marrow aspirate/biopsy.
- You will have x-rays taken of your bones.
This is an investigational study. Melphalan is FDA approved and commercially available for the treatment of MM. While receiving a stem-cell transplant is standard treatment for MM, cleaning (purging) the stem-cell product is investigational.
Up to 25 recipients will take part in this study. All will be enrolled at M. D. Anderson
- Conditions
- Multiple Myeloma
- Being tested
- Apheresis, Stem Cell Transplantation, Melphalan
- Keywords
- Myeloma, Ex-Vivo Depletion of Myeloma Cells, Peripheral Blood Progenitor Cell Grafts, PBPC, Stem Cell Transplant, Bone marrow stem cells, Melphalan, Alkeran, Apheresis
- 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.
ApheresisProcedure or surgery
On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation.
Stem Cell TransplantationProcedure or surgery
Co-culture Stem Cell Infusion on Day 0.
MelphalanDrug
Also called Alkeran
100 mg/m^2 IV over 30 minutes daily on Days -2 and -1
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell Collection + Transplantation | Experimental | Apheresis: On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. Co-culture Stem Cell Infusion on Day 0. Melphalan 100 mg/m^2 IV over 30 minutes daily on Days -2 and -1. Receives: Procedure: Apheresis; Procedure: Stem Cell Transplantation; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil Engraftment Rate
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yago Nieto, MD, PHD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968396
- Sponsor's protocol ID
- 2007-0886
- Status last verified
- Apr 2013
- First submitted
- 27 Aug 2009
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts
- ClinicalTrials.gov ID
- NCT00968396
- Acronym / sponsor ID
- 2007-0886
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Ex-Vivo Depletion of Myeloma Cells, Peripheral Blood Progenitor Cell Grafts, PBPC, Stem Cell Transplant, Bone marrow stem cells, Melphalan, Alkeran
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (estimated)
- First posted
- 31 Aug 2009 (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.
The goal of this clinical research study is to learn if cleaning the stem cells of a patient who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product capable of replacing the bone marrow after standard treatment with chemotherapy.
Detailed description
A transplant of one's own bone marrow stem cells is part of a standard treatment for MM. Because MM comes from the bone marrow, stem-cell products from the bone marrow can have tumor cells mixed in them when they are transplanted. This may cause the disease to return after transplant. This study will learn about a method of cleaning, or "purging," the MM tumor cells from the stem cells by using the bone marrow of a relative.
Study Drugs:
Melphalan is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be given G-CSF twice a day through a needle under the skin on Days 1-5 to move stem cells from out of the bone marrow and into the blood.
You will receive melphalan through a needle in your vein over 30 minutes each time on the 2 days directly before you receive the stem cell transplant.
Stem Cell Collection, Purging, and Transplantation:
On Day 5, stem cell collection will begin. You will have a central venous catheter (CVC - a sterile, flexible tube) placed into a vein in your chest while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
Blood will be removed from your body through the CVC and passed through a machine that separates stem cells from the other cells. The stem cells will be frozen for storage, and the blood will be returned to your body. This 3-hour process is called apheresis. This process will be done 1 time a day for 1-6 days, or until enough stem cells are collected.
Your stem cells will be placed in a sterile container, where they will grow and multiply with donated stem cells from a relative. If there are enough cells after 2 weeks, the cells will be transplanted back into the body. If there are not enough cells after the 2 weeks of growing with the donor's stem cells, they will be combined with a sample that was set aside at your initial collection and then transplanted back into the body.
Study Visits:
One (1), 2, and 6 months after the transplant, blood (about 2 teaspoons) will be drawn for routine tests and to check the status of the disease.
Six (6) months after the transplant, you will also have a bone marrow aspirate/biopsy to check the status of the disease.
Length of Study:
You will remain on study until 12 months after the transplant. You will be taken off study if the disease gets worse or needs further treatment.
End-of-Treatment Visit:
Twelve (12) months after the transplant, you will have your end-of-treatment visit. At this time, the following tests and procedures will be performed:
- Blood (about 2 teaspoons) will be drawn for routine tests and to check the status of the disease.
- You will have a bone marrow aspirate/biopsy.
- You will have x-rays taken of your bones.
This is an investigational study. Melphalan is FDA approved and commercially available for the treatment of MM. While receiving a stem-cell transplant is standard treatment for MM, cleaning (purging) the stem-cell product is investigational.
Up to 25 recipients will take part in this study. All will be enrolled at M. D. Anderson
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell Collection + Transplantation | Experimental | Procedure: Apheresis, Procedure: Stem Cell Transplantation, Drug: MelphalanApheresis: On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. Co-culture Stem Cell Infusion on Day 0. Melphalan 100 mg/m^2 IV over 30 minutes daily on Days -2 and -1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with multiple myeloma who have relapsed after an autologous transplant or with a chemosensitive relapse more than one year post initial therapy
- Age 18 to 75 years
- Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias
- FEV1, FVC and DLCO >/= 40%. No symptomatic pulmonary disease
- Serum bilirubin </= 2 x upper limit of normal, SGPT </= 4 x upper limit of normal
Key exclusion criteria (3 listed)
- International Staging System (ISS) stage I at diagnosis (beta-2 microglobulin < 3.5 mg/L and albumin >/= 3.5 g/dL)
- Patients with an apheresis collection </= 7 x 10e6 CD34+/Kg
- A fully matched related donor
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 |
|---|---|---|
| ApheresisOn Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. | Procedure or surgery | Stem Cell Collection + Transplantation |
| Stem Cell TransplantationCo-culture Stem Cell Infusion on Day 0. | Procedure or surgery | Stem Cell Collection + Transplantation |
| MelphalanAlso: Alkeran100 mg/m^2 IV over 30 minutes daily on Days -2 and -1 | Drug | Stem Cell Collection + Transplantation |
Primary outcome
Neutrophil Engraftment Rate
Time frame: 28 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Yago Nieto, MD, PHD study chair
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apheresis, Stem Cell Transplantation and Melphalan in people with Multiple Myeloma, run by M.D. Anderson Cancer Center.
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 3 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: withdrawn, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Neutrophil Engraftment Rate (time frame: 28 Days). 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 5 Apr 2013.