Multiple MyelomaPhase 1/2NCT02756728
A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma
A Phase 1/2 study testing BI-505, High dose melphalan and Autologous stem cell transplantation in people with Multiple Myeloma, run by BioInvent International AB at 1 site in United States.
Trial summary
The purpose of this study is to investigate the safety and efficacy of administering BI-505 in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma patients. 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?
- BI-505, High dose melphalan and Autologous stem cell transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2016
- Phase
- Phase 1/2
- 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
- A diagnosis of multiple myeloma by 2014 IMWG criteria and have been recommended to undergo HDM + ASCT as a standard-of-care therapy for their multiple myeloma.
- Subjects must have adequate vital organ function and functional status for HDM + ASCT
- Subjects must have collected and cryopreserved ≥4x106 hematopoietic stem cells per kg of actual body weight that are suitable for use in autologous stem cell transplantation in the judgment of the investigator.
- At the time of enrollment, subjects must have had at least a partial response, as defined by IMWG criteria and in comparison to baseline/pre-treatment parameters, to an induction regimen containing lenalidomide and/or bortezomib.
- Subjects must have measurable disease according to one of the following criteria:
- Serum M-spike ≥0.1 g/dl
Show all 9Show fewer
- Urine M-spike >200 mg in a 24-hour urine collection
- Involved serum free light chain above the upper limit of normal and a serum free light chain ratio outside the normal range.
- At the time of enrollment, subjects must be within 12 months of the first dose of initial/induction therapy, and the anticipated day of ASCT must be within 12 months of the first dose of initial/induction therapy
Who cannot join
- Prior allogeneic or autologous hematopoietic stem cell transplant
- Current active infections, including HIV and hepatitis C and B
- Autoimmune disease requiring ongoing immunosuppressive therapy.
- History of atrial fibrillation or flutter, including paroxysmal atrial fibrillation or flutter.
- History of transient ischemic attack or stroke.
- At the time of enrollment, subjects must not have required multi-agent continuous-infusion cytotoxic chemotherapy (e.g., regimens such as D-PACE) as part of their initial/induction therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman School of Medicine/Hospital of the Univ. of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Phase I/II Study of BI-505 in Conjunction With High-dose Melphalan and Autologous Stem Cell Transplantation for Multiple Myeloma
The purpose of this study is to investigate the safety and efficacy of administering BI-505 in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma patients.
Read the detailed description
N/A study is closed
- Conditions
- Multiple Myeloma
- Being tested
- BI-505, High dose melphalan, Autologous stem cell 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.
BI-505Biological
Treatment with BI-505 10 mg/kg bi-weekly infusion, up to 9 doses over 4 months
High dose melphalanOther
High dose melphalan (HDM)
Autologous stem cell transplantationOther
Autologous stem cell transplantation (ASCT)
| Study group | Role | What they receive |
|---|---|---|
| HDM+ASCT | Active comparator | Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation Receives: Other: High dose melphalan; Other: Autologous stem cell transplantation |
| BI-505 | Experimental | Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation Receives: Biological: BI-505; Other: High dose melphalan; Other: Autologous stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determine the safety and feasibility of administering BI-505 in conjunction with HDM+ASCT in multiple myeloma patients
UNK
Measured: Adverse events will be assessed within 30 days of ASCT in the safety part of the study.
Phase II: Determine the effect of BI-505 on rate of stringent complete response for multiple myeloma patients with measurable disease pre-ASCT.
UNK
Measured: At Day 100 after ASCT
Secondary outcomes (11)
Determine the effect of BI-505 on rate of stringent complete response (sCR) at day 100 in subgroups stratified according to response to initial therapy (+/- VGPR).
UNK
Measured: Day 100 after ASCT
Determine the effect of BI-505 administered in conjunction with HDM + ASCT on IMWG response category (PR, VGPR, CR, sCR) at one year post-ASCT and progression-free survival.
UNK
Measured: At one year and up to three years after ASCT
Evaluate the effect of BI-505 on MRD-negative rate at day 100 and change in MRD status at day 100 compared to baseline.
UNK
Measured: Day 100
Evaluate anti-myeloma effect of BI-505 monotherapy, prior to HDM + ASCT
UNK
Measured: Prior to HDM + ASCT (from Day -17 until Day 0)
Evaluate bone marrow immune cell composition and phenotype, including macrophage infiltration and expression of intracellular adhesion molecule (ICAM)-1 expression on multiple myeloma plasma cells, as potential biomarkers of response to BI-505
UNK
Measured: Day 100 compared to Baseline (Day -17 and Day -2)
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Cmax
Maximum Plasma Concentration (Cmax)
Measured: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Tmax
Time to reach Cmax (Tmax)
Measured: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing AUC
Area under the curve (AUC)
Measured: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing CL
Clearance (CL)
Measured: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Vss
Volume of distribution at steady state (Vss)
Measured: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing t1/2
Elimination half-life (t1/2)
Measured: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Full clinical hold from FDA
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioInvent International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfred Garfall, MD, Principal investigator, Div of Hema/Onc, Dept.of Med, Perelman Center Advanced Med, Philadelphia PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756728
- Sponsor's protocol ID
- 15-BI-505-03
- Status last verified
- Mar 2020
- First submitted
- 18 Apr 2016
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I/II Study of BI-505 in Conjunction With High-dose Melphalan and Autologous Stem Cell Transplantation for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02756728
- Acronym / sponsor ID
- 15-BI-505-03
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Full clinical hold from FDA
- Enrolment
- 5 participants (actual)
- Lead sponsor
- BioInvent International ABIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 29 Apr 2016 (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 investigate the safety and efficacy of administering BI-505 in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma patients.
Detailed description
N/A study is closed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HDM+ASCT | Active comparator | Other: High dose melphalan, Other: Autologous stem cell transplantationStandard of care; High dose Melphalan + Autologous Stem Cell Transplantation |
| BI-505 | Experimental | Biological: BI-505, Other: High dose melphalan, Other: Autologous stem cell transplantationBiweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A diagnosis of multiple myeloma by 2014 IMWG criteria and have been recommended to undergo HDM + ASCT as a standard-of-care therapy for their multiple myeloma.
- Subjects must have adequate vital organ function and functional status for HDM + ASCT
- Subjects must have collected and cryopreserved ≥4x106 hematopoietic stem cells per kg of actual body weight that are suitable for use in autologous stem cell transplantation in the judgment of the investigator.
- At the time of enrollment, subjects must have had at least a partial response, as defined by IMWG criteria and in comparison to baseline/pre-treatment parameters, to an induction regimen containing lenalidomide and/or bortezomib.
- Subjects must have measurable disease according to one of the following criteria:
Key exclusion criteria (6 listed)
- Prior allogeneic or autologous hematopoietic stem cell transplant
- Current active infections, including HIV and hepatitis C and B
- Autoimmune disease requiring ongoing immunosuppressive therapy.
- History of atrial fibrillation or flutter, including paroxysmal atrial fibrillation or flutter.
- History of transient ischemic attack or stroke.
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 |
|---|---|---|
| BI-505Treatment with BI-505 10 mg/kg bi-weekly infusion, up to 9 doses over 4 months | Biological | BI-505 |
| High dose melphalanHigh dose melphalan (HDM) | Other | BI-505, HDM+ASCT |
| Autologous stem cell transplantationAutologous stem cell transplantation (ASCT) | Other | BI-505, HDM+ASCT |
Primary outcome
Phase I: Determine the safety and feasibility of administering BI-505 in conjunction with HDM+ASCT in multiple myeloma patients
Time frame: Adverse events will be assessed within 30 days of ASCT in the safety part of the study.
UNK
Phase II: Determine the effect of BI-505 on rate of stringent complete response for multiple myeloma patients with measurable disease pre-ASCT.
Time frame: At Day 100 after ASCT
UNK
11 secondary outcomes
Determine the effect of BI-505 on rate of stringent complete response (sCR) at day 100 in subgroups stratified according to response to initial therapy (+/- VGPR).
Time frame: Day 100 after ASCT
Determine the effect of BI-505 administered in conjunction with HDM + ASCT on IMWG response category (PR, VGPR, CR, sCR) at one year post-ASCT and progression-free survival.
Time frame: At one year and up to three years after ASCT
Evaluate the effect of BI-505 on MRD-negative rate at day 100 and change in MRD status at day 100 compared to baseline.
Time frame: Day 100
Evaluate anti-myeloma effect of BI-505 monotherapy, prior to HDM + ASCT
Time frame: Prior to HDM + ASCT (from Day -17 until Day 0)
Evaluate bone marrow immune cell composition and phenotype, including macrophage infiltration and expression of intracellular adhesion molecule (ICAM)-1 expression on multiple myeloma plasma cells, as potential biomarkers of response to BI-505
Time frame: Day 100 compared to Baseline (Day -17 and Day -2)
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Cmax
Time frame: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Tmax
Time frame: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing AUC
Time frame: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing CL
Time frame: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Vss
Time frame: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing t1/2
Time frame: All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123
Results and safety
The study was stopped early (reason given: Full clinical hold from FDA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- 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.
Alfred Garfall, MD principal investigator
Div of Hema/Onc, Dept.of Med, Perelman Center Advanced Med, Philadelphia PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BI-505, High dose melphalan and Autologous stem cell transplantation in people with Multiple Myeloma, run by BioInvent International AB at 1 site in United States.
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 9 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: stopped early, as of the sponsor's last update on 12 Mar 2020. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Full clinical hold from FDA). Results are not available in the source record.
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?
Phase I: Determine the safety and feasibility of administering BI-505 in conjunction with HDM+ASCT in multiple myeloma patients (time frame: Adverse events will be assessed within 30 days of ASCT in the safety part of the study.). The study lists 2 primary outcomes in all. 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 Mar 2020.