Myeloma MultiplePhase 2NCT05338047
Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant
A Phase 2 study testing Pegfilgrastim in people with Myeloma Multiple and Lymphoma, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myeloma Multiple, Lymphoma
- What is being tested?
- Pegfilgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2022to 25 Feb 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing autologous peripheral blood stem cell transplantation
- Patients with multiple myeloma or lymphoma
- Adults (>18 years)
- Both genders
- Eastern Cooperative Oncology Group (ECOG) <=2
Who cannot join
- Alanine Aminotransferase or bilirubin values >2.5 times the superior normal limit
- Creatinin >2.2mg/dL
- Fever >37.6°C
- Active infection
- Hepatitis B, C or HIV infection
- Congestive heart failure (ejection fraction <40%)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, 66260
About this study
Official title: Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilgrastim for Neutrophil Recovery After Autologous Stem Cell Transplant
This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.
Read the detailed description
Thirty consecutive adults with lymphoma or myeloma receiving autologous peripheral blood stem cell transplant will be included in this phase 2 clinical trial. Patients will be allocated 1:1 in two groups: one subcutaneous 6 mg dose of generic pegfilgrastim (control group) or one 6mg dose of brand-name pegfilgrastim (intervention group) both at day +1 after the autotransplant. Daily complete blood counts were collected and time to neutrophil (>0.5x10^3/microL) and platelet recovery (>20x10^3/microL) will be obtained. The investigators will describe the proportion of adverse events and median time to neutrophil and platelet recoveries. Median or mean time to neutrophil recovery and time to platelet recovery will be calculated and compared with Mann-Whitney-Wilcoxon test or student T.
- Conditions
- Myeloma Multiple, Lymphoma
- Being tested
- Pegfilgrastim
- Keywords
- Autotransplant, Neutrophil recovery, Pegfilgrastim
- Medical subject headings
- Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegfilgrastimDrug
Also called Neulasta, Linkix
Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.
| Study group | Role | What they receive |
|---|---|---|
| Generic pegfilgrastim | Placebo comparator | One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant Receives: Drug: Pegfilgrastim |
| Brand name pegfilgrastim | Active comparator | One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant Receives: Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to neutrophil recovery
Time from autologous transplant to neutrophil count >0.5x10^3/microL
Measured: 15 days
Secondary outcomes (1)
Time to platelet recovery
Time from autologous transplant to platelet count >20x10^3/microL
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Apr 2022
- Primary completion25 Feb 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myeloma MultipleStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cesar Homero Gutierrez-Aguirre, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Cesar H Gutierrez Aguirre, Principal investigator, Hospital Universitario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338047
- Sponsor's protocol ID
- HE22-00006
- Status last verified
- Feb 2023
- First submitted
- 12 Apr 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jagasia MH, Greer JP, Morgan DS, Mineishi S, Kassim AA, Ruffner KL, Chen H, Schuening FG. Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study. Bone Marrow Transplant. 2005 Jun;35(12):1165-9. doi: 10.1038/sj.bmt.1704994.
PubMed 15880129Sheth V, Gore A, Jain R, Ghanekar A, Saikia T. Pegfilgrastim: More Cost Effective and Equally Efficacious Option as Compared to Filgrastim in Autologous Stem Cell Transplant. Indian J Hematol Blood Transfus. 2019 Jan;35(1):66-71. doi: 10.1007/s12288-018-0966-5. Epub 2018 May 17.
PubMed 30828150
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilgrastim for Neutrophil Recovery After Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT05338047
- Acronym / sponsor ID
- HE22-00006
- Conditions
- Myeloma Multiple, Lymphoma
- Keywords
- Autotransplant, Neutrophil recovery, Pegfilgrastim
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 20 Apr 2022 (actual)
- 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 a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.
Detailed description
Thirty consecutive adults with lymphoma or myeloma receiving autologous peripheral blood stem cell transplant will be included in this phase 2 clinical trial. Patients will be allocated 1:1 in two groups: one subcutaneous 6 mg dose of generic pegfilgrastim (control group) or one 6mg dose of brand-name pegfilgrastim (intervention group) both at day +1 after the autotransplant. Daily complete blood counts were collected and time to neutrophil (>0.5x10^3/microL) and platelet recovery (>20x10^3/microL) will be obtained. The investigators will describe the proportion of adverse events and median time to neutrophil and platelet recoveries. Median or mean time to neutrophil recovery and time to platelet recovery will be calculated and compared with Mann-Whitney-Wilcoxon test or student T.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic pegfilgrastim | Placebo comparator | Drug: PegfilgrastimOne 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant |
| Brand name pegfilgrastim | Active comparator | Drug: PegfilgrastimOne 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing autologous peripheral blood stem cell transplantation
- Patients with multiple myeloma or lymphoma
- Adults (>18 years)
- Both genders
- Eastern Cooperative Oncology Group (ECOG) <=2
Key exclusion criteria (6 listed)
- Alanine Aminotransferase or bilirubin values >2.5 times the superior normal limit
- Creatinin >2.2mg/dL
- Fever >37.6°C
- Active infection
- Hepatitis B, C or HIV infection
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 |
|---|---|---|
| PegfilgrastimAlso: Neulasta, LinkixSingle 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant. | Drug | Brand name pegfilgrastim, Generic pegfilgrastim |
Primary outcome
Time to neutrophil recovery
Time frame: 15 days
Time from autologous transplant to neutrophil count >0.5x10^3/microL
1 secondary outcome
Time to platelet recovery
Time frame: 15 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 28 Feb 2023.
- Results publication: PubMed 15880129Jagasia MH, Greer JP, Morgan DS, Mineishi S, Kassim AA, Ruffner KL, Chen H, Schuening FG. Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study. Bone Marrow Transplant. 2005 Jun;35(12):1165-9. doi: 10.1038/sj.bmt.1704994.
- Results publication: PubMed 30828150Sheth V, Gore A, Jain R, Ghanekar A, Saikia T. Pegfilgrastim: More Cost Effective and Equally Efficacious Option as Compared to Filgrastim in Autologous Stem Cell Transplant. Indian J Hematol Blood Transfus. 2019 Jan;35(1):66-71. doi: 10.1007/s12288-018-0966-5. Epub 2018 May 17.
- Individual participant dataSharing planned: No
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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.
Cesar H Gutierrez Aguirre principal investigator
Hospital Universitario
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 Pegfilgrastim in people with Myeloma Multiple and Lymphoma, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 5 inclusion and 6 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 28 Feb 2023. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
Time to neutrophil recovery (time frame: 15 days). 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 NCT05338047, which also lists 2 linked publications.
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 28 Feb 2023.