Non-Hodgkin's LymphomaPhase 4NCT00352703
PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
A Phase 4 study testing Kepivance (Palifermin) in people with Non-Hodgkin's Lymphoma and Multiple Myeloma, run by Swedish Orphan Biovitrum.
Trial summary
This is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous PBSCT for treating oral mucositis in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Multiple Myeloma
- What is being tested?
- Kepivance (Palifermin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to May 2007
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-Hodgkin's lymphoma (NHL) subjects scheduled to receive BEAM conditioning chemotherapy followed by autologous PBSCT, or multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan (200 mg/m2) conditioning chemotherapy, in a one or two-day schedule, followed by autologous PBSCT
- ≥Age 18 years
- ECOG performance status <= 2. In the MM group, ECOG status >2 will be accepted provided that it is exclusively due to MM (e.g. pathological fracture)
- Adequate pulmonary function as measured by a corrected carbon monoxide (CO) diffusing capacity (DLCO) ≥ 60% of predicted
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Minimum of 1.5 x 10^6 CD34+ cells/kg for autologous transplantation
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- Adequate haematological function (ANC ≥ 1.5 x 10^9/L and platelet count ≥ 100 x 10^9/L)
- Serum creatinine <= 2.0 mg/dL
- Total bilirubin <= 2 mg/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 4.0 x IULN
- Negative serum or urine pregnancy test for women of child bearing potential within 14 days prior to enrolment
- Each subject must give informed consent directly or through a legally acceptable representative before participating in any study specific procedure, or receiving any study medication. Exclusion Criteria:
- History of or concurrent cancer other than NHL or MM
- Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2)- Prior autologous or allogeneic transplants
- Oral abnormalities defined as baseline oral assessment of WHO grade >0
- Other investigational procedures are excluded
- Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
- Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding
- Subject is not using adequate contraceptive precautions
- Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Subject has known sensitivity to any of the products to be administered during dosing, including E coli-derived products
- Subject has previously been treated on this study or with other keratinocyte growth factors
- Unwilling or unable to complete the patient-reported outcome questionnaires
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Who cannot join
None listed.
About this study
Official title: An Open-label, Single-arm Study of Palifermin for Reduction of Mucositis in Subjects With Non-Hodgkin's Lymphoma or Multiple Myeloma Undergoing High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Transplantation
This is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose conditioning chemotherapy.
- Conditions
- Non-Hodgkin's Lymphoma, Multiple Myeloma
- Being tested
- Kepivance (Palifermin)
- Keywords
- Oral mucositis, Non-Hodgkin's lymphoma (NHL), conditioning chemotherapy, autologous PBSCT, multiple myeloma (MM), Melphalan
- Medical subject headings
- Lymphoma, Non-Hodgkin, Multiple Myeloma, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kepivance (Palifermin)Drug
| Study group | Role | What they receive |
|---|---|---|
| Kepivance (palifermin) 60 μg/kg/day IV | Experimental | 60 μg/kg/day IV for 3 consecutive days before the conditioning regimen and 3 consecutive days after the peripheral blood stem cell transplantation. Receives: Drug: Kepivance (Palifermin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4).
The study consisted of a screening period of up to 42 days to determine subject eligibility, followed by a treatment period of a maximum of 40 days.
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Biovitrum AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352703
- Sponsor's protocol ID
- 20050100
- Status last verified
- Oct 2014
- First submitted
- 13 Jul 2006
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study of Palifermin for Reduction of Mucositis in Subjects With Non-Hodgkin's Lymphoma or Multiple Myeloma Undergoing High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Transplantation
- ClinicalTrials.gov ID
- NCT00352703
- Acronym / sponsor ID
- 20050100
- Conditions
- Non-Hodgkin's Lymphoma, Multiple Myeloma
- Keywords
- Oral mucositis, Non-Hodgkin's lymphoma (NHL), conditioning chemotherapy, autologous PBSCT, multiple myeloma (MM), Melphalan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 17 Jul 2006 (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.
This is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose conditioning chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kepivance (palifermin) 60 μg/kg/day IV | Experimental | Drug: Kepivance (Palifermin)60 μg/kg/day IV for 3 consecutive days before the conditioning regimen and 3 consecutive days after the peripheral blood stem cell transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Non-Hodgkin's lymphoma (NHL) subjects scheduled to receive BEAM conditioning chemotherapy followed by autologous PBSCT, or multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan (200 mg/m2) conditioning chemotherapy, in a one or two-day schedule, followed by autologous PBSCT
- ≥Age 18 years
- ECOG performance status <= 2. In the MM group, ECOG status >2 will be accepted provided that it is exclusively due to MM (e.g. pathological fracture)
- Adequate pulmonary function as measured by a corrected carbon monoxide (CO) diffusing capacity (DLCO) ≥ 60% of predicted
- Left ventricular ejection fraction (LVEF) ≥ 50%
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Kepivance (Palifermin) | Drug | Kepivance (palifermin) 60 μg/kg/day IV |
Primary outcome
The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4).
Time frame: Up to 40 days
The study consisted of a screening period of up to 42 days to determine subject eligibility, followed by a treatment period of a maximum of 40 days.
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 3 Nov 2014.
- FDA-approved Drug LabelingLink 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.
MD study director
Biovitrum AB
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kepivance (Palifermin) in people with Non-Hodgkin's Lymphoma and Multiple Myeloma, run by Swedish Orphan Biovitrum.
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 24 inclusion and 0 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 3 Nov 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4). (time frame: Up to 40 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 3 Nov 2014.