Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00526734
High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Multiple Myeloma
A Phase 2 study testing filgrastim, pegfilgrastim and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Erasme University Hospital at 4 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as melphalan, use different ways to stop cancer cells from dividing so they stop growing or die. Stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- filgrastim, pegfilgrastim and melphalan
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2006to not given
- 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
- ECOG performance status 0-2
- ANC ≥ 1.0 x 10^9/L (without colony-stimulating factors)
- Platelet count ≥ 50 x 10^9/L (without transfusion support within the past 7 days)
- Serum calcium < 14 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN
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- Creatinine clearance ≥ 50 mL/min
- Fertile patients must use effective contraception
- Negative pregnancy test
- Willing and able to comply with protocol requirements
Who cannot join
- Myocardial infarction within the past 6 months
- New York Heart Association class III or IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmia
- Acute ischemia or active conduction system abnormalities as evidenced by ECG
- Serious medical condition that could prolong hematological recovery or preclude completion of or tolerance to protocol therapy
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- Seropositive for HIV antibody
- Known hepatitis B surface antigen positivity OR active hepatitis C infection
- Active systemic infection requiring treatment
- Pregnant or nursing
- Poor psychiatric condition
- PRIOR CONCURRENT THERAPY:
- No plasmapheresis within the past 4 weeks
- No major surgery within the past 4 weeks
- No anticancer therapy within the past 5 years, except treatment for basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
- No other concurrent G-CSF growth factors
- No concurrent enrollment in another investigational clinical trial
- No concurrent investigational agent that would contraindicate the use of pegfilgrastim as either a mobilization agent or a hematological recovery agent
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Poland3 sites, 3 recruiting
- Recruiting
Medical University of Gdansk
Gdansk, 80-211
Andrzej W. Hellmann, MD, PhD, 48- 58-349-2230
- Recruiting
Silesian Medical Academy
Katowice, 40-029
Jerzy Holowiecki, MD, PhD, 48-32-256-2858, holow@slam.katowice.pl
- Recruiting
Institute of Haematology and Blood Transfusion
Warsaw, 00-957
Krzysztof Warzocha, MD, PhD, 48-22-849-8507, warzocha@ihit.waw.pl
Belgium1 site, 1 recruiting
- Recruiting
Hopital Universitaire Erasme
Brussels, 1070
Walter Feremans, MD, PhD, 32-2-555-3660, wfereman@ulb.ac.be
About this study
Official title: A Randomised, International, Open-label, Phase II Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization and Engraftment With Pegfilgrastim or Filgrastim for Autologous Transplantation in Patients With Multiple Myeloma (MM)
RATIONALE: Drugs used in chemotherapy, such as melphalan, use different ways to stop cancer cells from dividing so they stop growing or die. Stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Giving colony-stimulating factors, such as G-CSF or pegfilgrastim, helps stem cells move from the bone marrow to the blood so they can be collected. It is not yet known which regimen is more effective in treating multiple myeloma.
PURPOSE: This randomized phase II trial is studying how well high-dose chemotherapy followed by stem cell transplant works in treating patients with newly diagnosed stage I, stage II, or stage III multiple myeloma.
Read the detailed description
OBJECTIVES:
Primary
- Compare engraftment of peripheral blood progenitor cells (PBPCs) mobilized by 2 different fixed doses of pegfilgrastim versus a by-weight dose of filgrastim (G-CSF).
Secondary
- Determine the ability of 2 different fixed doses of pegfilgrastim to mobilize PBPCs.
- Determine the safety of pegfilgrastim during PBPC mobilization and collection.
- Determine the effect of different induction chemotherapy regimens on autologous progenitor cell transplantation.
OUTLINE: This is a multicenter study. Patients are stratified by type of induction chemotherapy (Thal/Dex vs VAD vs Vel-Dex vs VTD) and by stage of disease according to International Prognostic Index criteria (stage I [i.e., beta-2 microglobulin < 3.5 and albumin > 35] vs stages II and III).
- Induction therapy: Patients receive 3-4 courses of 1 of the following regimens:
- VAD: Patients receive vincristine, doxorubicin hydrochloride, and dexamethasone.
- Thal/Dex: Patients receive thalidomide and dexamethasone.
- Vel-Dex: Patients receive bortezomib and dexamethasone.
- VTD: Patients receive bortezomib, thalidomide, and dexamethasone. Patients achieving complete, partial, or minimal response after 3-4 courses of induction therapy proceed to peripheral blood progenitor cell (PBPC) mobilization 17 days after completion of induction therapy.
- PBPC mobilization: Patients are randomized to 1 of 3 arms.
- Arm I: Patients receive filgrastim subcutaneously (SC) once daily until the final leukapheresis.
- Arm II: Patients receive a single dose of pegfilgrastim SC.
- Arm III: Patients receive pegfilgrastim as in arm II at a higher dose.
- Leukapheresis: Patients undergo up to 3 leukaphereses to obtain adequate numbers of CD34-positive filgrastim- or pegfilgrastim-mobilized PBPCs for engraftment. Patients achieving a sufficient number of collected PBSCs proceed to conditioning chemotherapy.
- Conditioning chemotherapy: Patients receive high-dose melphalan* IV over 1-2 days. Patients then proceed to PBPC transplantation.
NOTE: *Patients ≥ 65 years old receive melphalan at a lower dose.
- Autologous PBPC transplantation: Patients undergo infusion of PBPCs on day 0. Patients in all arms receive G-CSF support beginning on day 1 after PBPC transplantation and continuing until blood counts recover for 3 consecutive days.
After completion of study therapy, patients are followed for up to 100 days post-transplantation.
- Being tested
- filgrastim, pegfilgrastim, melphalan, autologous hematopoietic stem cell transplantation
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- 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.
filgrastimBiological
pegfilgrastimBiological
melphalanDrug
autologous hematopoietic stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with engraftment after induction chemotherapy
Secondary outcomes (12)
Number and proportion of patients from whom ≥ 2 x 10e6 CD34-positive cells/kg are harvested
Number and proportion of patients from whom ≥ 4 x 10e6 CD34-positive cells/kg are harvested
CD34-positive cells/kg yield in each leukapheresis
Number of leukaphereses to collect ≥ 2 x 10e6 CD34-positive cells/kg
Number of leukaphereses to collect ≥ 4 x 10e6 CD34-positive cells/kg
Proportion of patients with platelet recovery ≥ 20 x 10e9/L in the absence of transfusion for at least 7 days
Proportion of patients with ANC recovery of ≥ 0.5 x 10e9/L
Time to neutrophil recovery, defined as the time to neutrophil engraftment (i.e., ANC ≥ 0.5 x 10e9/L for 3 consecutive days)
Time to ANC ≥ 1.0 x 10e9/L
Time to platelet recovery, defined as the time to platelets ≥ 20 x 10e9/L in the absence of platelet transfusion support for at least 7 days
Incidence and duration of hospitalization during mobilization phase and during post-transplantation phase
Incidence and severity of adverse events during and after the use of pegfilgrastim 12 mg or pegfilgrastim 18 mg and filgrastim
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- 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
- Randomised
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Walter Feremans, MD, PhD, Study chair, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526734
- Sponsor's protocol ID
- ERA-2006-001
- Other IDs
- CDR0000561733, ERA-NEUMOBIL, EUDRACT-2006-000891-34
- Status last verified
- Sep 2007
- First submitted
- 5 Sep 2007
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, International, Open-label, Phase II Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization and Engraftment With Pegfilgrastim or Filgrastim for Autologous Transplantation in Patients With Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT00526734
- Acronym / sponsor ID
- ERA-2006-001
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Feb 2006
- First posted
- 10 Sep 2007 (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.
RATIONALE: Drugs used in chemotherapy, such as melphalan, use different ways to stop cancer cells from dividing so they stop growing or die. Stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Giving colony-stimulating factors, such as G-CSF or pegfilgrastim, helps stem cells move from the bone marrow to the blood so they can be collected. It is not yet known which regimen is more effective in treating multiple myeloma.
PURPOSE: This randomized phase II trial is studying how well high-dose chemotherapy followed by stem cell transplant works in treating patients with newly diagnosed stage I, stage II, or stage III multiple myeloma.
Detailed description
OBJECTIVES:
Primary
- Compare engraftment of peripheral blood progenitor cells (PBPCs) mobilized by 2 different fixed doses of pegfilgrastim versus a by-weight dose of filgrastim (G-CSF).
Secondary
- Determine the ability of 2 different fixed doses of pegfilgrastim to mobilize PBPCs.
- Determine the safety of pegfilgrastim during PBPC mobilization and collection.
- Determine the effect of different induction chemotherapy regimens on autologous progenitor cell transplantation.
OUTLINE: This is a multicenter study. Patients are stratified by type of induction chemotherapy (Thal/Dex vs VAD vs Vel-Dex vs VTD) and by stage of disease according to International Prognostic Index criteria (stage I [i.e., beta-2 microglobulin < 3.5 and albumin > 35] vs stages II and III).
- Induction therapy: Patients receive 3-4 courses of 1 of the following regimens:
- VAD: Patients receive vincristine, doxorubicin hydrochloride, and dexamethasone.
- Thal/Dex: Patients receive thalidomide and dexamethasone.
- Vel-Dex: Patients receive bortezomib and dexamethasone.
- VTD: Patients receive bortezomib, thalidomide, and dexamethasone. Patients achieving complete, partial, or minimal response after 3-4 courses of induction therapy proceed to peripheral blood progenitor cell (PBPC) mobilization 17 days after completion of induction therapy.
- PBPC mobilization: Patients are randomized to 1 of 3 arms.
- Arm I: Patients receive filgrastim subcutaneously (SC) once daily until the final leukapheresis.
- Arm II: Patients receive a single dose of pegfilgrastim SC.
- Arm III: Patients receive pegfilgrastim as in arm II at a higher dose.
- Leukapheresis: Patients undergo up to 3 leukaphereses to obtain adequate numbers of CD34-positive filgrastim- or pegfilgrastim-mobilized PBPCs for engraftment. Patients achieving a sufficient number of collected PBSCs proceed to conditioning chemotherapy.
- Conditioning chemotherapy: Patients receive high-dose melphalan* IV over 1-2 days. Patients then proceed to PBPC transplantation.
NOTE: *Patients ≥ 65 years old receive melphalan at a lower dose.
- Autologous PBPC transplantation: Patients undergo infusion of PBPCs on day 0. Patients in all arms receive G-CSF support beginning on day 1 after PBPC transplantation and continuing until blood counts recover for 3 consecutive days.
After completion of study therapy, patients are followed for up to 100 days post-transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ECOG performance status 0-2
- ANC ≥ 1.0 x 10^9/L (without colony-stimulating factors)
- Platelet count ≥ 50 x 10^9/L (without transfusion support within the past 7 days)
- Serum calcium < 14 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Key exclusion criteria (18 listed)
- Myocardial infarction within the past 6 months
- New York Heart Association class III or IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmia
- Acute ischemia or active conduction system abnormalities as evidenced by ECG
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 |
|---|---|---|
| filgrastim | Biological | – |
| pegfilgrastim | Biological | – |
| melphalan | Drug | – |
| autologous hematopoietic stem cell transplantation | Procedure or surgery | – |
Primary outcome
Number of patients with engraftment after induction chemotherapy
12 secondary outcomes
Number and proportion of patients from whom ≥ 2 x 10e6 CD34-positive cells/kg are harvested
Number and proportion of patients from whom ≥ 4 x 10e6 CD34-positive cells/kg are harvested
CD34-positive cells/kg yield in each leukapheresis
Number of leukaphereses to collect ≥ 2 x 10e6 CD34-positive cells/kg
Number of leukaphereses to collect ≥ 4 x 10e6 CD34-positive cells/kg
Proportion of patients with platelet recovery ≥ 20 x 10e9/L in the absence of transfusion for at least 7 days
Proportion of patients with ANC recovery of ≥ 0.5 x 10e9/L
Time to neutrophil recovery, defined as the time to neutrophil engraftment (i.e., ANC ≥ 0.5 x 10e9/L for 3 consecutive days)
Time to ANC ≥ 1.0 x 10e9/L
Time to platelet recovery, defined as the time to platelets ≥ 20 x 10e9/L in the absence of platelet transfusion support for at least 7 days
Incidence and duration of hospitalization during mobilization phase and during post-transplantation phase
Incidence and severity of adverse events during and after the use of pegfilgrastim 12 mg or pegfilgrastim 18 mg and filgrastim
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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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.
Walter Feremans, MD, PhD study chair
Erasme University Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, pegfilgrastim and melphalan in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Erasme University Hospital at 4 sites in 2 countries.
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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland, Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with engraftment after induction chemotherapy. 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 12 Aug 2013.