Multiple MyelomaPhase 2NCT00948922
Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma
A Phase 2 study testing Bortezomib, Melphalan and Autologous Stem Cell Transplant in people with Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib, Melphalan and Autologous 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
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2009to 14 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple Myeloma Criteria(International Uniform Response Criteria for Multiple Myeloma)
- Patients with responsive disease after any line of induction therapy
- A complete response
- A very good partial response
- A partial response
- Patients greater than or equal to 18 years of age are eligible. There is upper age limit of 60 years for allogeneic transplants.
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- Patients must have a histologically confirmed diagnosis.
- All patients should have a life expectancy of at least 12 weeks.
- Patients must have undergone a complete psychosocial evaluation and have been considered capable of compliance.
- Meet the following criteria for allogeneic hematopoietic cell transplant:
- Must have an identified donor match defined as: HLA-A, HLA-B, HLA- C, DRB1 8/8 allele matched sibling, family member, or unrelated donor. [7/8 would go on separate mismatched trials] and be < 60 years of age.
- Calculated hematopoietic cell transplantation-specific comorbidity index (HCT-CI) <3
Who cannot join
- Patients who do not achieve at least a partial response (PR) by the criteria mentioned above with induction therapy.
- Patient has a platelet count of <30 x 10^9/L within 14 days before enrollment.
- Patient has >/= Grade 2 peripheral neuropathy within 30 days before enrollment.
- Patient has an absolute neutrophil count of <1.0 x 10^9/L within 30 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant in order for the subject to be considered eligible. Left ventricular ejection fraction (LVEF) by multiple gated acquisition (MUGA) scan < 40%.
- Patient has hypersensitivity to bortezomib, boron or mannitol.
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- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs with 30 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Patients with a diffusing capacity of lung for carbon monoxide (DLCO) less than 50% (adjusted) of normal or with symptomatic obstructive or restrictive lung disease are ineligible.
- Patients with a total bilirubin greater than 2.0 mg/dL excluding Gilbert's syndrome and serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) greater than two and a half times normal (unless due to primary malignancy), or a history of severe hepatic dysfunction are ineligible.
- Calculated creatinine clearance </= 30 ml/min within 30 days before enrollment
- Patients with active infections are ineligible.
- Patients who are HIV positive are ineligible.
- Patients with active leptomeningeal involvement are ineligible. Patients with a history of previous cerebrospinal fluid (CSF) tumor involvement without symptoms or signs are eligible provided the CSF is now free of disease on lumbar puncture, and MRI of the brain shows no tumor involvement. Patients with severe symptomatic central nervous system (CNS) disease of any etiology are ineligible.
- Patients with uncontrolled insulin-dependent diabetes mellitus defined as a random glucose level of > 400 in the 30 days prior to initiation of study therapy; or uncompensated major thyroid or adrenal dysfunction are ineligible.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of >/= 2(Karnofsky < 50%) are ineligible.
- Patients with an ECOG performance status of 2 to 3(Karnofsky 30-50%), secondary to bone pain, may be enrolled.
- Patients with an ECOG performance status of 2 to 3(Karnofsky 30-50%), secondary to a potentially reversible disease-related problem, may be enrolled.
- Patients with any previous malignancy other than non-melanoma skin cancer are ineligible, unless the patient is without evidence of disease >/= 5 years after the treatment for the cancer was completed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma After Cytoreductive Therapy
The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma.
Read the detailed description
The primary objectives of this study are:
- To determine the 2 year-progression free survival in multiple myeloma with an allogeneic transplant using a conditioning regimen of melphalan + fludarabine + Bortezomib in patients < 60 years of age and available HLA-matched donor and compare it with the 2 year-progression-free-survival after an autologous stem cell transplant with melphalan+Bortezomib conditioning in patients < 60 years.
- To determine the 2 year-progression free survival in multiple myeloma with an autologous stem cell transplant using a conditioning regimen of melphalan + Bortezomib. for patients > 60 years of age and patients < 60 years of age who decline allogeneic stem cell transplant.
The secondary objectives of this study are:
- To determine the overall survival in multiple myeloma with autologous or allogeneic stem cell transplants using the above conditioning regimens
- To determine the response rates in multiple myeloma using the above regimens.
- To determine minimal residual disease status using allele specific oligonucleotides (ASO-PCR) by PCR and flow-cytometry for multiple myeloma cells.
- To correlate minimal residual disease status with 2 year progression free survival and overall survival.
- To determine the incidence of acute and chronic graft-versus-host disease (GVHD) in multiple myeloma with allogeneic stem cell transplant using the above conditioning regimen.
- To examine quality of life in patients treated with allogeneic and autologous stem cell transplants using the above conditioning regimen.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib, Melphalan, Autologous Stem Cell Transplant, Fludarabine, Allogeneic Stem Cell Transplant
- Keywords
- multiple myeloma, myeloma, myeloma proteins, autologous, allogeneic, G-CSR, granulocyte colony-stimulating factor, stem cell transplant, stem cell, stem cell mobilization
- 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.
BortezomibDrug
Also called Velcade
AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).
MelphalanDrug
Also called Alkeran(R)
AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes.
Autologous Stem Cell TransplantProcedure or surgery
Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells.
FludarabineDrug
Also called Fludara(R)
Days -6,-5,-4,-3 Fludarabine 30 mg/m^2/day IV
Allogeneic Stem Cell TransplantProcedure or surgery
Allogeneic Stem Cell Transplant: Allogeneic Peripheral Blood Stem Cell Rescue. Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients. Allogeneic donor stem cells may also be cryopreserved if they cannot be infused fresh.
| Study group | Role | What they receive |
|---|---|---|
| A: Allogeneic Stem Cell Transplant | Other | Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue. Receives: Drug: Bortezomib; Drug: Melphalan; Drug: Fludarabine; Procedure: Allogeneic Stem Cell Transplant |
| B: Autologous Stem Cell Transplant | Other | Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue. Receives: Drug: Bortezomib; Drug: Melphalan; Procedure: Autologous Stem Cell Transplant |
| BE: Group B Expansion | Other | Group B Expansion on Bortezomib Maintenance: Autologous Only. Receives: Drug: Bortezomib; Drug: Melphalan; Procedure: Autologous Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS: Number of participants, per treatment arm with progression free survival at time of analysis. Survival time will be measured from the date of transplant to the date of progression, death or the last follow-up, whichever comes first. Progressive Disease (PD): Increase of ≥ 25% from lowest response value in any one or more of the following: Serum M-component and/or; Urine M-component and/or; Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage ≥ 10%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.
Measured: End of 2 year, post transplant follow-up
Secondary outcomes (2)
Overall Survival (OS) Rate
Overall survival in participants with multiple myeloma treated with Bortezomib (Velcade®) containing conditioning regimen and autologous as well as allogeneic transplantation.
Measured: End of 2 year, post transplant follow-up
Molecular Complete Response (CR) Rates in Patients With Multiple Myeloma
Complete Response according to International Myeloma Working Group uniform response criteria. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow.
Measured: End of 2 year, post transplant follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study start18 Jun 2009
- Primary completion20 Apr 2017
- Study completion14 May 2019
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 H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Melissa Alsina, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research InstituteJose Ochoa-Bayona, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948922
- Sponsor's protocol ID
- MCC-15697
- Other IDs
- XO5271
- Status last verified
- Jun 2019
- First submitted
- 28 Jul 2009
- Last updated
- 18 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma After Cytoreductive Therapy
- ClinicalTrials.gov ID
- NCT00948922
- Acronym / sponsor ID
- MCC-15697
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, myeloma, myeloma proteins, autologous, allogeneic, G-CSR, granulocyte colony-stimulating factor, stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- 18 Jun 2009 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Posted 12 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma.
Detailed description
The primary objectives of this study are:
- To determine the 2 year-progression free survival in multiple myeloma with an allogeneic transplant using a conditioning regimen of melphalan + fludarabine + Bortezomib in patients < 60 years of age and available HLA-matched donor and compare it with the 2 year-progression-free-survival after an autologous stem cell transplant with melphalan+Bortezomib conditioning in patients < 60 years.
- To determine the 2 year-progression free survival in multiple myeloma with an autologous stem cell transplant using a conditioning regimen of melphalan + Bortezomib. for patients > 60 years of age and patients < 60 years of age who decline allogeneic stem cell transplant.
The secondary objectives of this study are:
- To determine the overall survival in multiple myeloma with autologous or allogeneic stem cell transplants using the above conditioning regimens
- To determine the response rates in multiple myeloma using the above regimens.
- To determine minimal residual disease status using allele specific oligonucleotides (ASO-PCR) by PCR and flow-cytometry for multiple myeloma cells.
- To correlate minimal residual disease status with 2 year progression free survival and overall survival.
- To determine the incidence of acute and chronic graft-versus-host disease (GVHD) in multiple myeloma with allogeneic stem cell transplant using the above conditioning regimen.
- To examine quality of life in patients treated with allogeneic and autologous stem cell transplants using the above conditioning regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Allogeneic Stem Cell Transplant | Other | Drug: Bortezomib, Drug: Melphalan, Drug: Fludarabine, Procedure: Allogeneic Stem Cell TransplantAllogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue. |
| B: Autologous Stem Cell Transplant | Other | Drug: Bortezomib, Drug: Melphalan, Procedure: Autologous Stem Cell TransplantAutologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue. |
| BE: Group B Expansion | Other | Drug: Bortezomib, Drug: Melphalan, Procedure: Autologous Stem Cell TransplantGroup B Expansion on Bortezomib Maintenance: Autologous Only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Multiple Myeloma Criteria(International Uniform Response Criteria for Multiple Myeloma)
- Patients with responsive disease after any line of induction therapy
- A complete response
- A very good partial response
- A partial response
Key exclusion criteria (20 listed)
- Patients who do not achieve at least a partial response (PR) by the criteria mentioned above with induction therapy.
- Patient has a platelet count of <30 x 10^9/L within 14 days before enrollment.
- Patient has >/= Grade 2 peripheral neuropathy within 30 days before enrollment.
- Patient has an absolute neutrophil count of <1.0 x 10^9/L within 30 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant in order for the subject to be considered eligible. Left ventricular ejection fraction (LVEF) by multiple gated acquisition (MUGA) scan < 40%.
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: VelcadeAUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion). | Drug | A: Allogeneic Stem Cell Transplant, B: Autologous Stem Cell Transplant, BE: Group B Expansion |
| MelphalanAlso: Alkeran(R)AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes. | Drug | A: Allogeneic Stem Cell Transplant, B: Autologous Stem Cell Transplant, BE: Group B Expansion |
| Autologous Stem Cell TransplantAutologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells. | Procedure or surgery | B: Autologous Stem Cell Transplant, BE: Group B Expansion |
| FludarabineAlso: Fludara(R)Days -6,-5,-4,-3 Fludarabine 30 mg/m^2/day IV | Drug | A: Allogeneic Stem Cell Transplant |
| Allogeneic Stem Cell TransplantAllogeneic Stem Cell Transplant: Allogeneic Peripheral Blood Stem Cell Rescue. Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients. Allogeneic donor stem cells may also be cryopreserved if they cannot be infused fresh. | Procedure or surgery | A: Allogeneic Stem Cell Transplant |
Primary outcome
Progression Free Survival (PFS)
Time frame: End of 2 year, post transplant follow-up
PFS: Number of participants, per treatment arm with progression free survival at time of analysis. Survival time will be measured from the date of transplant to the date of progression, death or the last follow-up, whichever comes first. Progressive Disease (PD): Increase of ≥ 25% from lowest response value in any one or more of the following: Serum M-component and/or; Urine M-component and/or; Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage ≥ 10%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.
2 secondary outcomes
Overall Survival (OS) Rate
Time frame: End of 2 year, post transplant follow-up
Molecular Complete Response (CR) Rates in Patients With Multiple Myeloma
Time frame: End of 2 year, post transplant follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- H. Lee Moffitt Cancer Center \& Research Institute websiteLink provided by the sponsor.
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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.
Melissa Alsina, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
Jose Ochoa-Bayona, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 Bortezomib, Melphalan and Autologous Stem Cell Transplant in people with Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute 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 12 inclusion and 20 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: finished, as of the sponsor's last update on 18 Sep 2019. 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 12 Oct 2018). 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?
Progression Free Survival (PFS) (time frame: End of 2 year, post transplant follow-up). 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 18 Sep 2019.