Multiple MyelomaPhase 2V-BEAMNCT01653418
Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation
A Phase 2 study testing Bortezomib, Carmustine and Etoposide in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) is the most commonly used conditioning regimen for relapsed/refractory lymphoma patients needing autologous stem cell transplantation. 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, Carmustine and Etoposide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have a histologically confirmed diagnosis of multiple myeloma.
- Patient must have received a prior autologous stem cell transplantation with melphalan conditioning for multiple myeloma with subsequent disease progression and repeat autologous stem cell transplantation is deemed appropriate by the treating physicians.
- Patient must receive induction chemotherapy including 2 to 4 cycles of anti-myeloma therapy including bortezomib, with or without immune modulating agents and/or corticosteroids, Completion of induction therapy will occur within 30 days of first study drug dose.
- Patient must have ≥ 2x106/kg CD34+ autologous stem cells available for transplantation.
- Patient must be ≥ 18 years of age.
- Patient must have life expectancy of greater than 6 months.
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- Patient must have an ECOG performance status ≤ 2 or Karnofsky performance status ≥ 60% (see Appendices A and B)
- Patient must have normal bone marrow and organ function as defined below within 14 days prior to first study drug dose (conditioning regimen):
- Absolute neutrophil count ≥500/mm3
- Platelets ≥ 50,000/mm3
- Hemoglobin ≥ 8 g/dl
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Creatinine clearance (Appendix C) ≥30 mL/min/1.73m2
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry through Day +100 visit. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Patient must be able to understand and willing to sign an IRB approved written informed consent document.
- -Both men and women and members of all races and ethnic groups are eligible for this trial.
Who cannot join
- Patient must not be refractory to induction therapy. Refractory is defined as disease progression while on therapy or within 30 days following completion of therapy.
- Patient must not have had disease progression requiring active treatment within 12 months of previous autologous stem cell transplant. Maintenance therapy is not considered active treatment.
- Patient must not have peripheral neuropathy ≥ grade 3 based on NCI CTCAE v 4.0 (Appendix D).
- Patient must not be receiving renal replacement therapy, hemodialysis, or peritoneal dialysis.
- Patient must not have another concurrent malignancy requiring treatment.
- Patient must not be receiving any other investigational agents within 14 days prior to the first dose of study drug.
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- Patient must not have known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, carmustine, etoposide, cytarabine, and melphalan, or other agents used in the study.
- Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient must not be pregnant and/or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63122
About this study
Official title: A Phase II Study of V-BEAM (Bortezomib, Carmustine, Etoposide, Cytarabine, and Melphalan) as Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation for Multiple Myeloma
BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) is the most commonly used conditioning regimen for relapsed/refractory lymphoma patients needing autologous stem cell transplantation. Since these components are all effective in myeloma and bortezomib has shown promising results in the transplant setting, here the investigators propose a phase II study to investigate the combination of bortezomib and BEAM as a new conditioning regimen for patients who relapse or progress after the first autologous transplantation and for whom a second autologous transplant is considered.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib, Carmustine, Etoposide, Cytarabine, Melphalan
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Velcade
CarmustineDrug
Also called BCNU, BiCNU®
EtoposideDrug
Also called Vepesid, VP-16
CytarabineDrug
Also called Ara-C, Cytosar-U, 1-β-Arabinofuranosylcytosine, Arabinosylcytosine, Cytosine arabinoside
MelphalanDrug
Also called Alkeran®, L-PAM
Stem cell infusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| V-BEAM + Stem Cell Infusion | Experimental | Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0 Receives: Drug: Bortezomib; Drug: Carmustine; Drug: Etoposide; Drug: Cytarabine; Drug: Melphalan; Procedure: Stem cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (Complete Response + Stringent Complete Response)
Defined by the International Myeloma Working Group (IMWG) criteria
Measured: Day +100
Secondary outcomes (8)
Number of Participants With Progression-free Survival (PFS)
PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission.
Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.
Measured: Median follow-up of 6 months (range: 6.0-12.0 months)
Overall Response Rate (ORR)
ORR includes Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR)
Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.
Measured: 3 months following Day +100 visit
Very Good Partial Response Rate (VGPR+nCR+sCR+CR)
Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.
Measured: Day +100
Toxicity of V-BEAM
Graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.
This outcomes measures the common toxicities observed. Please refer to the Serious Adverse Event and Other Adverse Event sections of the results for further details.
Measured: 30 days after end of treatment / Day +100
Time to Neutrophil Engraftment After V-BEAM.
Time to neutrophil engraftment is defined as duration between Day 0 to the first day of ANC > 0.5x109/L post transplant when it is sustained for more than three consecutive days.
Measured: Day +100
Number of Participants With Overall Survival (OS)
OS is defined as the duration from the time of transplant to death or last follow-up.
Measured: Median follow-up of 6 months (range: 6-12 months)
Treatment Related Mortality (TRM) of V-BEAM
Measured: Day +100
Time to Platelet Engraftment After V-BEAM.
Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at > 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.
Measured: Day +100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionDec 2013
Why it stopped: Due to the high rate of morbidity and mortality
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 Washington University School of MedicineThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Vij, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653418
- Sponsor's protocol ID
- 201208046
- Acronym
- V-BEAM
- Status last verified
- Oct 2014
- First submitted
- 23 Jul 2012
- Last updated
- 15 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of V-BEAM (Bortezomib, Carmustine, Etoposide, Cytarabine, and Melphalan) as Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01653418
- Acronym / sponsor ID
- V-BEAM / 201208046
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the high rate of morbidity and mortality
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 15 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) is the most commonly used conditioning regimen for relapsed/refractory lymphoma patients needing autologous stem cell transplantation. Since these components are all effective in myeloma and bortezomib has shown promising results in the transplant setting, here the investigators propose a phase II study to investigate the combination of bortezomib and BEAM as a new conditioning regimen for patients who relapse or progress after the first autologous transplantation and for whom a second autologous transplant is considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V-BEAM + Stem Cell Infusion | Experimental | Drug: Bortezomib, Drug: Carmustine, Drug: Etoposide, Drug: Cytarabine, Drug: Melphalan, Procedure: Stem cell infusionBortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient must have a histologically confirmed diagnosis of multiple myeloma.
- Patient must have received a prior autologous stem cell transplantation with melphalan conditioning for multiple myeloma with subsequent disease progression and repeat autologous stem cell transplantation is deemed appropriate by the treating physicians.
- Patient must receive induction chemotherapy including 2 to 4 cycles of anti-myeloma therapy including bortezomib, with or without immune modulating agents and/or corticosteroids, Completion of induction therapy will occur within 30 days of first study drug dose.
- Patient must have ≥ 2x106/kg CD34+ autologous stem cells available for transplantation.
- Patient must be ≥ 18 years of age.
Key exclusion criteria (10 listed)
- Patient must not be refractory to induction therapy. Refractory is defined as disease progression while on therapy or within 30 days following completion of therapy.
- Patient must not have had disease progression requiring active treatment within 12 months of previous autologous stem cell transplant. Maintenance therapy is not considered active treatment.
- Patient must not have peripheral neuropathy ≥ grade 3 based on NCI CTCAE v 4.0 (Appendix D).
- Patient must not be receiving renal replacement therapy, hemodialysis, or peritoneal dialysis.
- Patient must not have another concurrent malignancy requiring treatment.
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: Velcade | Drug | V-BEAM + Stem Cell Infusion |
| CarmustineAlso: BCNU, BiCNU® | Drug | V-BEAM + Stem Cell Infusion |
| EtoposideAlso: Vepesid, VP-16 | Drug | V-BEAM + Stem Cell Infusion |
| CytarabineAlso: Ara-C, Cytosar-U, 1-β-Arabinofuranosylcytosine, Arabinosylcytosine, Cytosine arabinoside | Drug | V-BEAM + Stem Cell Infusion |
| MelphalanAlso: Alkeran®, L-PAM | Drug | V-BEAM + Stem Cell Infusion |
| Stem cell infusion | Procedure or surgery | V-BEAM + Stem Cell Infusion |
Primary outcome
Complete Response Rate (Complete Response + Stringent Complete Response)
Time frame: Day +100
Defined by the International Myeloma Working Group (IMWG) criteria
8 secondary outcomes
Number of Participants With Progression-free Survival (PFS)
Time frame: Median follow-up of 6 months (range: 6.0-12.0 months)
Overall Response Rate (ORR)
Time frame: 3 months following Day +100 visit
Very Good Partial Response Rate (VGPR+nCR+sCR+CR)
Time frame: Day +100
Toxicity of V-BEAM
Time frame: 30 days after end of treatment / Day +100
Time to Neutrophil Engraftment After V-BEAM.
Time frame: Day +100
Number of Participants With Overall Survival (OS)
Time frame: Median follow-up of 6 months (range: 6-12 months)
Treatment Related Mortality (TRM) of V-BEAM
Time frame: Day +100
Time to Platelet Engraftment After V-BEAM.
Time frame: Day +100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Ravi Vij, M.D. principal investigator
Washington University School of 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 Bortezomib, Carmustine and Etoposide in people with Multiple Myeloma, run by Washington University School of Medicine 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 17 inclusion and 10 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 15 Oct 2014. 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 15 Oct 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?
Complete Response Rate (Complete Response + Stringent Complete Response) (time frame: Day +100). 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 15 Oct 2014.