Multiple MyelomaPhase 2NCT01105403
Exploratory Study on POL6326 in Stem Cell Mobilization
A Phase 2 study testing POL6326 in people with Multiple Myeloma, run by Polyphor Ltd. at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- POL6326
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Apr 2014
- 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
- Have multiple myeloma in Stage II or III, according to the criteria of Durie and Salmon.
- Male or female between 18 and 70 years of age, inclusive. Male and females capable of reproduction must agree to use adequate contraceptive measures (e.g. condom, intrauterine device, oral contraceptive) until 3 months after termination of treatment.
- Measurable disease, defined by one of the following:
- Serum M protein ≥1.0 g/dL by protein electrophoresis
- Quantifiable immunoglobulin levels and/or
- urinary M protein excretion ≥200 mg/24 hours.
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- All patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2.
- Life expectancy of >6 months.
- Have given their written informed consent to participate in the study
Who cannot join
- Have non-secretory myeloma and/or plasma cell leukaemia.
- History of other malignancies during the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma, or localised prostate carcinoma.
- Any other clinically significant medical conditions.
- History of cardiac disease NHYA classification ≥3.
- Insufficient bone marrow, liver and renal function as assessed by the following clinical laboratory evaluations:
- Haemoglobin <9.0 g/L. Absolute neutrophil count <1500/µL. Platelet count <50000/µL. Total bilirubin >1.5 x upper limit of normal (ULN). Alanine aminotransferase (ALT) and alkaline phosphatase (AP) >2.5 x ULN. Amylase and lipase >1.5 x ULN. Serum creatinine >2.0 x ULN. Prothrombin time (PT) and activated partial thrombo-plastin time (aPTT) >1.5 x ULN.
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- Pregnant or lactating female patients.
- Known history of HIV infection or chronic hepatitis B or C infection.
- Receipt of immunotherapy, radiation therapy, or any investigational drug within 30 days of study drug administration.
- Prior radiotherapy to more than 3 vertebrae.
- Active serious bacterial or fungal infections; >grade 3 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- Receipt of haematopoietic cytokines within 10 days of study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa, Proof of Concept Study is to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients With Multiple Myeloma
The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation
- Conditions
- Multiple Myeloma
- Being tested
- POL6326
- Keywords
- Hematopoietic stem cells, Mobilisation, Autologous transplantation
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POL6326Drug
Also called not appicable
IV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood
| Study group | Role | What they receive |
|---|---|---|
| CD34+ mobilisation for transplantation | Experimental | Not described Receives: Drug: POL6326 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma
Number of patients achieving the minimal number of CD34+ cells (≥2 x 10 mill/kg BW) collected during one to four cycles of apheresis which are considered necessary and safe to proceed with autotransplantation
Number of apheresis cycles required to obtain the minimal number of CD34+ cells necessary for autotransplantation (≥2 x 10 mill/kg BW)
Measured: Up to four days
Secondary outcomes (2)
To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma
Measured: 2 months
To determine the efficacy of POL6326 in reconstitution of immune system after transplantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2009
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyphor Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hartmut Goldschmidt, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105403
- Sponsor's protocol ID
- POL-2
- Status last verified
- Apr 2014
- First submitted
- 13 Apr 2010
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Proof of Concept Study is to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01105403
- Acronym / sponsor ID
- POL-2
- Conditions
- Multiple Myeloma
- Keywords
- Hematopoietic stem cells, Mobilisation, Autologous transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Polyphor Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Apr 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.
The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD34+ mobilisation for transplantation | Experimental | Drug: POL6326 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have multiple myeloma in Stage II or III, according to the criteria of Durie and Salmon.
- Male or female between 18 and 70 years of age, inclusive. Male and females capable of reproduction must agree to use adequate contraceptive measures (e.g. condom, intrauterine device, oral contraceptive) until 3 months after termination of treatment.
- Measurable disease, defined by one of the following:
- All patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2.
Key exclusion criteria (12 listed)
- Have non-secretory myeloma and/or plasma cell leukaemia.
- History of other malignancies during the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma, or localised prostate carcinoma.
- Any other clinically significant medical conditions.
- History of cardiac disease NHYA classification ≥3.
- Insufficient bone marrow, liver and renal function as assessed by the following clinical laboratory evaluations:
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 |
|---|---|---|
| POL6326Also: not appicableIV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood | Drug | CD34+ mobilisation for transplantation |
Primary outcome
To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma
Time frame: Up to four days
Number of patients achieving the minimal number of CD34+ cells (≥2 x 10 mill/kg BW) collected during one to four cycles of apheresis which are considered necessary and safe to proceed with autotransplantation Number of apheresis cycles required to obtain the minimal number of CD34+ cells necessary for autotransplantation (≥2 x 10 mill/kg BW)
2 secondary outcomes
To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma
Time frame: 2 months
To determine the efficacy of POL6326 in reconstitution of immune system after transplantation
Time frame: 1 year
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 23 Apr 2014.
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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.
Hartmut Goldschmidt, MD principal investigator
Heidelberg University
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 POL6326 in people with Multiple Myeloma, run by Polyphor Ltd. at 1 site in Germany.
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 12 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 23 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 Germany. 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?
To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma (time frame: Up to four 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 23 Apr 2014.