Multiple MyelomaPhase 2REMYKIRNCT00999830
Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma
A Phase 2 study testing IPH2101 in people with Multiple Myeloma, run by Innate Pharma at 9 sites in France.
Trial summary
This is an open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two dose regimens of IPH2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- IPH2101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 9 sitesFrance
- Study dates
- Sep 2009to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MM which initially required a systemic therapy and received a first line treatment, conventional doses of chemotherapies or high dose chemotherapy and an autologous transplantation of hematopoietic cells, followed or not by a consolidation treatment.
- Residual disease considered as evaluable with:
- Quantifiable serum M-protein: ≥ 3 g/l, except for spike in the beta globulin area. In this particular case serum M-protein is considered quantifiable if ≥ 10g/l
- If serum M-protein is < 3g/l, measurable involved Free Light Chains ≥ 100 mg/l and an abnormal Free Light chains ratio (<0.26 or > 1.65)
- Responses which are partial (PR and VGPR) and in plateau
- Partial response should meet the IMWG uniform response criteria: a ≥ 50% reduction from value of serum M-protein before the first line chemotherapy treatment and a reduction in 24h urinary M-protein by ≥ 90% or to < 200 mg /24h;
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- Very good partial response according to the IMWG uniform response criteria with 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg/24h; furthermore the M-protein should spike in the gamma globulin area;
- Plateau phase is defined by :
- For patients with serum M-protein ≥ 3g/l: stable levels of M-protein in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. Fluctuations of ± 25 % and ± 2 g/l in Serum M-protein levels are allowed.
- For Patients with serum M-protein < 3g/l: stable levels Free Light Chains in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. Fluctuations of ± 25 % of involved serum Free Light Chain are allowed.
- ECOG performance status of 0, 1 or 2.
- Clinical laboratory values at screening:
- Calculated creatinine clearance (according to MDRD) > 50 ml/min
- Platelet > 50 x 109 /l
- ANC > 1 x 109 /l
- Bilirubin levels < 1.5 ULN; ALT and AST < 2.5 ULN
- Male or female patient who accepts and is able to use recognised effective contraception (oral contraceptives, IUCD, barrier method of contraception in conjunction with spermicidal jelly) throughout the study.
- Signed inform consent obtained before any trial-related activities
Who cannot join
- Age < 18 years old or > 75 years old
- Previous consolidation/ maintenance therapy by Imid (thalidomide, lenalidomid) or bortezomib within the last 2 months
- Treatment with chemotherapy, systemic corticosteroid within the previous 2 months
- Treatment with growth factors (EPO, G- or GM-CSF) within the previous 1 month
- Radiotherapy for bone or visceral lesion within the last 3 months
- Use of any investigational agent within the last 2 months
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- Primary or associated amyloidosis
- Peripheral neuropathy of grade ≥ III according to the CTCAE of the NCI
- Abnormal cardiac status with any of the following
- NYHA stage III or IV congestive heart failure
- myocardial infarction within the previous 6 months
- symptomatic cardiac arrhythmia despite treatment
- Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen
- History of or current auto-immune disease
- Serious concurrent uncontrolled medical disorder
- History of other malignancy for less then 5 years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma)
- History of allogenic hematopoietic cell or solid organ transplantation
- Pregnant or lactating women
- Any medical condition which is regarded by the investigator as incompatible with the study participation
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
C.H.R.U. de Caen - Hôpital Bretonneau
Caen, 14033
CHU Dijon
Dijon, 21079
CHRU Lille
Lille, 59037
Hôpital Dupuytren
Limoges, 87042
Institut Paoli Calmettes
Marseille, 13273
CHU Nancy
Nancy, 54511
Hopital Saint Louis
Paris, 75010
Hôpital Saint Antoine
Paris, 75012
C.H.R.U. de Tours
Tours, 37044
About this study
Official title: Randomised Phase II Study Evaluating the Anti-tumour Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Human Monoclonal Anti-KIR Antibody, in Patients With Multiple Myeloma in Stable Partial Response After a First Line Therapy
This is an open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two dose regimens of IPH2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy.
Read the detailed description
Development of new treatments for diseases such as multiple myeloma is a focus for research. The research being conducted is on treatment called Anti-KIR, which activates the body's own cells to kill tumor cells. This is different from many other treatments where chemicals are given to kill tumor cells.The primary objective of the study is to evaluate the clinical activity of two different dose regimens (0.2 mg/kg, leading to an intermittent saturation of NK receptors and 2mg/kg leading to a sustained saturation of NK receptors) of IPH2101 administered as a single agent in multiple myeloma patients who achieved, after the completion of any first line treatment, including conventional or high dose chemotherapies, a stable partial or very good partial response (PR or VGPR).
- Conditions
- Multiple Myeloma
- Being tested
- IPH2101
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPH2101Drug
Also called Fully human anti-KIR monoclonal antibody (1-7F9)
One infusion of IPH2101 every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| IPH 2101 0.2 mg/kg | Experimental | One infusion of IPH2101 every 4 weeks at the dose of 0.2 mg/kg by intravenous route over 1 hour, for 4 or up to 8 cycles. Receives: Drug: IPH2101 |
| IPH2101 2.0 mg/kg | Experimental | One infusion of IPH2101 every 4 weeks at the dose of 2 mg/kg by intravenous route over 1 hour, for 4 or up to 8 cycles. Receives: Drug: IPH2101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Patients Achieving a Response Based on M-protein or Free Light Chains
Response was defined:
- In patients with a serum M-protein > 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval;
- In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis
- In patients with serum M-protein < 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (<0.26 or > 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels.
Measured: From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices
Secondary outcomes (2)
Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment
KIR-occupancy is a relative measure of the fraction of cell surface KIR that is occupied by the IPH2101 monoclonal antibody, and hence is unavailable for binding to HLA ligands.
Measured: From the start up to the end of study (15 months)
Safety Assessment
Adverse Events, Serious Adverse Events, physical examination and biological changes.
Measured: from screening visit to the End of Study (at each study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innate Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel ATTAL, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999830
- Sponsor's protocol ID
- IPH2101-201
- Acronym
- REMYKIR
- Status last verified
- Apr 2014
- First submitted
- 21 Oct 2009
- Last updated
- 24 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase II Study Evaluating the Anti-tumour Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Human Monoclonal Anti-KIR Antibody, in Patients With Multiple Myeloma in Stable Partial Response After a First Line Therapy
- ClinicalTrials.gov ID
- NCT00999830
- Acronym / sponsor ID
- REMYKIR / IPH2101-201
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Innate PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Posted 24 Mar 2016
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 randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two dose regimens of IPH2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy.
Detailed description
Development of new treatments for diseases such as multiple myeloma is a focus for research. The research being conducted is on treatment called Anti-KIR, which activates the body's own cells to kill tumor cells. This is different from many other treatments where chemicals are given to kill tumor cells.The primary objective of the study is to evaluate the clinical activity of two different dose regimens (0.2 mg/kg, leading to an intermittent saturation of NK receptors and 2mg/kg leading to a sustained saturation of NK receptors) of IPH2101 administered as a single agent in multiple myeloma patients who achieved, after the completion of any first line treatment, including conventional or high dose chemotherapies, a stable partial or very good partial response (PR or VGPR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPH 2101 0.2 mg/kg | Experimental | Drug: IPH2101One infusion of IPH2101 every 4 weeks at the dose of 0.2 mg/kg by intravenous route over 1 hour, for 4 or up to 8 cycles. |
| IPH2101 2.0 mg/kg | Experimental | Drug: IPH2101One infusion of IPH2101 every 4 weeks at the dose of 2 mg/kg by intravenous route over 1 hour, for 4 or up to 8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- MM which initially required a systemic therapy and received a first line treatment, conventional doses of chemotherapies or high dose chemotherapy and an autologous transplantation of hematopoietic cells, followed or not by a consolidation treatment.
- Residual disease considered as evaluable with:
- Responses which are partial (PR and VGPR) and in plateau
- ECOG performance status of 0, 1 or 2.
- Clinical laboratory values at screening:
Key exclusion criteria (20 listed)
- Age < 18 years old or > 75 years old
- Previous consolidation/ maintenance therapy by Imid (thalidomide, lenalidomid) or bortezomib within the last 2 months
- Treatment with chemotherapy, systemic corticosteroid within the previous 2 months
- Treatment with growth factors (EPO, G- or GM-CSF) within the previous 1 month
- Radiotherapy for bone or visceral lesion within the last 3 months
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 |
|---|---|---|
| IPH2101Also: Fully human anti-KIR monoclonal antibody (1-7F9)One infusion of IPH2101 every 4 weeks | Drug | IPH 2101 0.2 mg/kg, IPH2101 2.0 mg/kg |
Primary outcome
Rate of Patients Achieving a Response Based on M-protein or Free Light Chains
Time frame: From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices
Response was defined: * In patients with a serum M-protein > 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval; * In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis * In patients with serum M-protein < 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (<0.26 or > 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels.
2 secondary outcomes
Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment
Time frame: From the start up to the end of study (15 months)
Safety Assessment
Time frame: from screening visit to the End of Study (at each study visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michel ATTAL, MD principal investigator
University Hospital, Toulouse
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPH2101 in people with Multiple Myeloma, run by Innate Pharma at 9 sites in France.
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 18 inclusion and 20 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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Patients Achieving a Response Based on M-protein or Free Light Chains (time frame: From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices). 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 24 Mar 2016.