MyelomaPhase 2PAVNCT01220375

PAV-trial: Plerixafor and Chemotherapy With Vinorelbine for Stem Cell Mobilization in Patients With Myeloma

A Phase 2 study testing Vinorelbine, G-CSF, & Plerixafor, Vinorelbine and Plerixafor and G-CSF and Plerixafor in people with Myeloma, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Myeloma
What is being tested?: Vinorelbine, G-CSF, & Plerixafor, Vinorelbine and Plerixafor and G-CSF and Plerixafor
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteSwitzerland
Study dates: Apr 2010to Oct 2013
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic stage I or stage II and III myeloma patients after standard first-line non-melphalan containing induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.
Standard induction chemotherapy comprises regimens including thalidomide, bortezomib, or lenalidomide (up to 4 cycles), alone or in combination with dexamethasone. Combinations of novel agents are allowed as well as induction with the VAD regimen.
Patients must have achieved at least a partial response according to the Bladé criteria after induction chemotherapy.
Patient must be aged 18-70 years, with an ECOG < 2 and has given voluntary written informed consent.
Platelets count 50 x 109/l without transfusion support within 7 days before the laboratory test.
Absolute neutrophil count (ANC) 1.0 x 109/l without the use of colony stimulating factors.

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Corrected serum calcium < 3 mmol/L.
Aspartate transaminase (AST) <= 1.5 x ULN.
Alanine transaminase (ALT) <= 1.5 x ULN.
Total bilirubin <= 2 x ULN.
Creatinin-clearance >= 50 ml/min.
Negative pregnancy test within 14 days prior to registration for all women of childbearing potential. Patients of childbearing potential must implement adequate measures to avoid pregnancy during study treatment and for additional 12 months. No pregnant or lactating patients are allowed.

Who cannot join

Patients previously treated with melphalan or extensive radiotherapy to the bone marrow.
Patients with more than 4 cycles of chemotherapy with Lenalidomide.
Patients not fit for autologous stem cell transplantation.
Patient receiving colony stimulating factors.
Patient underwent plasmaphereses within 4 weeks before enrolment.
Patient had major surgery within 4 weeks before enrolment.

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Patient has other serious medical condition that could potentially interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery.
Sero-positive for HIV antibody.
Patient known to be hepatitis B surface antigen positive or who has an active hepatitis C infection.
Patient has an active systemic infection requiring treatment.
Female patient is pregnant or breast feeding.
Compromised renal function as evidenced by measured or calculated creatinine clearance <= 50 ml/min.
Subject is currently enrolled in, or has not yet completed at least 30 days since ending another investigational device or drug trial or is receiving other investigational agent.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Dep. of Medical Oncology, Bern University Hospital
Bern, 3010

Other trials in Switzerland

About this study

Official title: PAV-trial: Plerixafor and Chemotherapy With Vinorelbine for Stem Cell Mobilization in Patients With Myeloma. A Pilot Phase II Study.

Read the detailed description

Background

High-dose chemotherapy with autologous stem cell support is the current standard procedure in the first-line treatment in younger patients with myeloma fit for intensive treatment. Current practice in Switzerland for stem cell mobilization is the combination of chemotherapy and G-CSF stimulation in myeloma patients fit for high-dose chemotherapy with melphalan and autologous stem cell transplant. For mobilization chemotherapy, a single dose of vinorelbine is commonly used, producing mild myelosuppression. G-CSF is started at day 4 on a daily basis, allowing stem cell apheresis usually at day 8. In a subsequent study, we evaluated the use of pegylated G-CSF given as a single injection at day 4 together with vinorelbine. We found this regimen equally feasible, reliable and allowing collection of stem cells in an equally high percentage. In the current proposal, we suggest to continue this line of research investigating the mobilization using chemotherapy with vinorelbine. We propose to study the feasibility of this mobilization chemotherapy in the absence of growth factors, thus without G-CSF, in combination with Plerixafor.

Objective

Primary objective: To assess the feasibility of collection of > 6 million CD34+ peripheral blood stem cells/kg body weight in 2 days.

Secondary objectives: Assessment of safety of plerixafor during mobilization and collection of peripheral blood stem cells; feasibility of intravenous plerixafor application and stem cell apheresis in a one-day procedure on an ambulatory basis; evaluation of engraftment of peripheral blood stem cells mobilized by vinorelbine and plerixafor; evaluation of the costs for mobilization with plerixafor.

Methods

Chemotherapy with vinorelbine is given at a standard dose at day 1, on an ambulatory basis.

In part A (10 patients), G-CSF is given s.c., divided in two daily doses starting at day 4 until collection of stem cells. Plerixafor is given as an i.v. application on day 8 in the dose of 240 microg/kg b.w. Stem cell collection is initiated 4 hours later at day 8, if at least 20 x 103 of CD34+ cells / ml peripheral blood are detected. In case of insufficient collection, the procedure is repeated at day 9, including repetition of plerixafor application.

Part B (30 patients): If the combination of plerixafor and vinorelbine is found feasible and in the absence of unexpected toxicity, additional 30 patients will be studied in part B of this study. No G-CSF will be administered in part B, otherwise the treatment plan is as it is in part A.

High dose Melphalan will be used as conditioning regimen. After transplantation, G-CSF will be given to subjects starting at day +5 after PBPC reinfusion.

Conditions: Myeloma
Being tested: Vinorelbine, G-CSF, & Plerixafor, Vinorelbine and Plerixafor, G-CSF and Plerixafor, Vinorelbine & Plerixafor on day when CD34 count is at least 15'000 CD34+ cells/ml of peripheral blood
Keywords: Mobilization of autologous peripheral blood progenitor cells PBPC, Autologous stem cell mobilization, Multiple Myeloma, Plerixafor
Medical subject headings: Neoplasms, Plasma Cell, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vinorelbine, G-CSF, & PlerixaforDrug
Patients 1-10 receive 35 mg/m2 vinorelbine i.v. on day 1, G-CSF divided in two daily doses from day 4 until collection of stem cells, and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.
Vinorelbine and PlerixaforDrug
Patients 11-20 receive 35 mg/m2 vinorelbine i.v. on day 1 and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. No G-CSF will be administered. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.
G-CSF and PlerixaforDrug
Patients 21-30 receive G-CSF divided in two daily doses from day 4 until collection of stem cells, and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. No chemotherapy with vinorelbine will be gine on day 1. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.
Vinorelbine & Plerixafor on day when CD34 count is at least 15'000 CD34+ cells/ml of peripheral bloodDrug
Patients 31-40 receive 35 mg/m2 vinorelbine i.v. on day 1 and plerixafor as an i.v. application at 08:00 AM, on the first day on which the CD34 count has risen to at least 15'000 CD34+ cells/ml of peripheral blood. Stem cell collection is initiated 4 hours later (at 12:00 PM) on this day. No G-CSF will be administered.

Study groups in NCT01220375
Study group	Role	What they receive
1	Experimental	Plerixafor is a bicyclam with hematopoietic stem cell-mobilizing activity. Plerixafor blocks the binding of stromal cell-derived factor (SDF-1alpha) to the cellular receptor CXCR4, resulting in hematopoietic stem cell release from bone marrow and HSC movement into the peripheral circulation. Receives: Drug: Vinorelbine, G-CSF, & Plerixafor; Drug: Vinorelbine and Plerixafor; Drug: G-CSF and Plerixafor; Drug: Vinorelbine & Plerixafor on day when CD34 count is at least 15'000 CD34+ cells/ml of peripheral blood

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients from whom ≥ 6 million CD34+ peripheral blood stem cells/kg are harvested in a maximum of 2 days
Measured: day 8 (and 9, if necessary) / 2 days after G-CSF

Secondary outcomes (3)

Incidence and severity of adverse events during and after the use of plerixafor
Measured: 15 days
Proportion of patients with engraftment of PBPC defined as an ANC recovery of ≥ 0.5 x 109/L for 3 consecutive days and a platelet recovery of ≥ 20 x 109/L in the absence of platelet transfusion for at least 7 days
Measured: 21 months
Comparison of costs for mobilization of PBPC with vinorelbine and plerixafor versus the costs for mobilization with vinorelbine and filgrastim and versus the costs for mobilization with vinorelbine and pegfilgrastim
Measured: 21 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Oct 2013

First posted13 Oct 2010 (estimated)
Study startApr 2010
Primary completionJan 2012
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MyelomaStudies of the same condition, open and under way.
More trials run by Insel Gruppe AG, University Hospital BernThe 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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01220375
Sponsor's protocol ID: 236/09
Other IDs: 2010DR2052, 10-CPRS-001, 1795
Acronym: PAV
Status last verified: Apr 2014
First submitted: 11 Oct 2010
Last updated: 17 Apr 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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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
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All Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PAV-trial: Plerixafor and Chemotherapy With Vinorelbine for Stem Cell Mobilization in Patients With Myeloma. A Pilot Phase II Study.
ClinicalTrials.gov ID: NCT01220375
Acronym / sponsor ID: PAV / 236/09
Conditions: Myeloma
Keywords: Mobilization of autologous peripheral blood progenitor cells PBPC, Autologous stem cell mobilization, Multiple Myeloma, Plerixafor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Insel Gruppe AG, University Hospital BernUniversity, hospital or other
Study start: Apr 2010
Primary completion: Jan 2012 (actual)
Study completion: Oct 2013 (actual)
First posted: 13 Oct 2010 (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.

Detailed description

Background

Objective

Primary objective: To assess the feasibility of collection of > 6 million CD34+ peripheral blood stem cells/kg body weight in 2 days.

Methods

Chemotherapy with vinorelbine is given at a standard dose at day 1, on an ambulatory basis.

High dose Melphalan will be used as conditioning regimen. After transplantation, G-CSF will be given to subjects starting at day +5 after PBPC reinfusion.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Vinorelbine, G-CSF, & Plerixafor, Drug: Vinorelbine and Plerixafor, Drug: G-CSF and Plerixafor, Drug: Vinorelbine & Plerixafor on day when CD34 count is at least 15'000 CD34+ cells/ml of peripheral bloodPlerixafor is a bicyclam with hematopoietic stem cell-mobilizing activity. Plerixafor blocks the binding of stromal cell-derived factor (SDF-1alpha) to the cellular receptor CXCR4, resulting in hematopoietic stem cell release from bone marrow and HSC movement into the peripheral circulation.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Symptomatic stage I or stage II and III myeloma patients after standard first-line non-melphalan containing induction treatment. Patients must be fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.
Standard induction chemotherapy comprises regimens including thalidomide, bortezomib, or lenalidomide (up to 4 cycles), alone or in combination with dexamethasone. Combinations of novel agents are allowed as well as induction with the VAD regimen.
Patients must have achieved at least a partial response according to the Bladé criteria after induction chemotherapy.
Patient must be aged 18-70 years, with an ECOG < 2 and has given voluntary written informed consent.
Platelets count 50 x 109/l without transfusion support within 7 days before the laboratory test.

Key exclusion criteria (13 listed)

Patients previously treated with melphalan or extensive radiotherapy to the bone marrow.
Patients with more than 4 cycles of chemotherapy with Lenalidomide.
Patients not fit for autologous stem cell transplantation.
Patient receiving colony stimulating factors.
Patient underwent plasmaphereses within 4 weeks before enrolment.

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
Vinorelbine, G-CSF, & PlerixaforPatients 1-10 receive 35 mg/m2 vinorelbine i.v. on day 1, G-CSF divided in two daily doses from day 4 until collection of stem cells, and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.	Drug	1
Vinorelbine and PlerixaforPatients 11-20 receive 35 mg/m2 vinorelbine i.v. on day 1 and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. No G-CSF will be administered. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.	Drug	1
G-CSF and PlerixaforPatients 21-30 receive G-CSF divided in two daily doses from day 4 until collection of stem cells, and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. No chemotherapy with vinorelbine will be gine on day 1. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.	Drug	1
Vinorelbine & Plerixafor on day when CD34 count is at least 15'000 CD34+ cells/ml of peripheral bloodPatients 31-40 receive 35 mg/m2 vinorelbine i.v. on day 1 and plerixafor as an i.v. application at 08:00 AM, on the first day on which the CD34 count has risen to at least 15'000 CD34+ cells/ml of peripheral blood. Stem cell collection is initiated 4 hours later (at 12:00 PM) on this day. No G-CSF will be administered.	Drug	1

Primary outcome

Number of patients from whom ≥ 6 million CD34+ peripheral blood stem cells/kg are harvested in a maximum of 2 days
Time frame: day 8 (and 9, if necessary) / 2 days after G-CSF

3 secondary outcomes

Incidence and severity of adverse events during and after the use of plerixafor
Time frame: 15 days
Proportion of patients with engraftment of PBPC defined as an ANC recovery of ≥ 0.5 x 109/L for 3 consecutive days and a platelet recovery of ≥ 20 x 109/L in the absence of platelet transfusion for at least 7 days
Time frame: 21 months
Comparison of costs for mobilization of PBPC with vinorelbine and plerixafor versus the costs for mobilization with vinorelbine and filgrastim and versus the costs for mobilization with vinorelbine and pegfilgrastim
Time frame: 21 Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.

Related trials for 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)
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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.

Thomas Pabst, Associate Professor principal investigator

Dep. Medical Oncology, Bern University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 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 17 Apr 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 Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of patients from whom ≥ 6 million CD34+ peripheral blood stem cells/kg are harvested in a maximum of 2 days (time frame: day 8 (and 9, if necessary) / 2 days after G-CSF). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01220375.

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 17 Apr 2014.