Smoldering Multiple MyelomaPhase 2KIRMONONCT01222286
Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma
A Phase 2 study testing IPH2101 in people with Smoldering Multiple Myeloma, run by Innate Pharma at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Smoldering 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
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2010to Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SMM of any risk level according to a definition derived of the International Myeloma Working Group definition ( Br J Haematol 2003; 121: 749) : Serum M protein ≥ 3 g/dl , AND/OR Bone Marrow plasma cells ≥ 10 % with no evidence of end-organ damage (CRAB)
- (C)Absence of hypercalcemia : Ca < 10.5 mg/dl
- (R)Absence of renal failure : creatinine < 2mg/dl (177 μmol/l) or calculated creatinine clearance(according to MDRD) > 50 ml/min
- (A)Absence of anemia : Hb > 11 g/dl
- (B)Absence of lytic bone lesion on standard skeletal survey (MRI could be used if clinically indicated)
- Measurable disease defined as a disease with a serum M protein ≥ 1 g/dl
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- No evidence of fatigue, recurrent infections or any clinical suspicion of MM
- Diagnosis of SMM confirmed on two consecutive assessments (ie fluctuation under 25% of serum protein level) performed with at least a 4 week interval.
- Age > 18 years or < 75 years
- ECOG performance status of 0 or 1
- 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 when relevant
- Informed consent signed by the patient
Who cannot join
- Previous treatment having a proven or potential impact on myelomatous cells proliferation or survival (including IMiDs or proteasome inhibitors, conventional chemotherapies within the last 5 years, steroids within the last month prior to enrolment). Previous bisphosphonates started less than 3 months prior to enrolment.
- Use of any investigational agent within the last 3 months
- Clinical laboratory values at screening
- Platelet < 75 x 10^9 /l
- ANC < 1.5 x 10^9 /l
- Bilirubin levels >1.5 ULN ; ALT and AST > 3 ULN (grade 1 NCI)
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- Primary or associated amyloidosis
- 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 requiring treatment or persisting despite appropriate treatment
- Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen
- History of or current auto-immune disease
- History of other active malignancy within the past five years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma).
- Serious concurrent uncontrolled medical disorder
- History of allograft or solid organ transplantation
- Pregnant or lactating women
- Any condition potentially hampering compliance with the study protocol and follow-up schedule
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Ohio State University
Columbus, Ohio, 43210
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Mount Sinai School of Medicine
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Multicenter Phase II Study on the Anti-tumor Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Fully Human Monoclonal Anti KIR Antibody, in Patients With Smoldering Multiple Myeloma (KIRMONO)
The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma.
Read the detailed description
This is a randomized Phase II, open label, multi-centre study, with two independent arms.
Patients receive 6 injections of IPH2101, at the dose of 0.2 mg/kg or 2 mg/kg (according to their randomization) administered over one hour infusion at four weeks intervals.
A patient whose disease achieves at least a minimal response to study treatment at any time during the initial period of 6 cycles can be treated with an additional period of treatment of 6 cycles.
Patients are followed 6 months after treatment completion or until a KIR occupancy level < 30% (i.e if the time required for KIR desaturation was > 6 months), whichever is longer.
- Conditions
- Smoldering Multiple Myeloma
- Being tested
- IPH2101
- Keywords
- Smoldering Multiple Myeloma
- Medical subject headings
- Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPH2101Drug
Also called a human monoclonal anti-KIR antibody (1-7F9)
0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
| Study group | Role | What they receive |
|---|---|---|
| IPH2101 0.2 mg/kg | Experimental | 0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles Receives: Drug: IPH2101 |
| IPH2101 2 mg/kg | Experimental | 2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 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 an Objective Response
The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.
Measured: from start to end of study (14 months)
Secondary outcomes (3)
Safety Assessment
adverse events, physical examination and biological changes during the whole clinical trial.
Measured: Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
Pharmacodynamics of IPH2101
biological activity of IPH2101 on KIR occupancy at End of Treatment
Measured: from start to end of study (14 months)
Secondary Anti-tumor Activity
- any change of M-protein in serum occurring during the study (>25 percentage increase in level of serum M-protein)
- progression to active Multiple Myeloma
Definition of active Multiple Myeloma: Evidence of progression based on the IMWG criteria for progressive disease in myeloma and any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder :
- Development of new soft tissue plasmacytomas or bone lesions
- Hypercalcemia (> 11mg/100ml)
- Decrease in hemoglobin of > 2g/100ml
- Rise in serum creatinine by 2 mg/100ml or more
Measured: from start to end of study (14 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2012
- Study completionJan 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 Smoldering 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innate Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikhil Munshi, MD, Principal investigator, Dana-Farber Cancer Institute- Medical Oncology- Boston MA-USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222286
- Sponsor's protocol ID
- IPH2101-203
- Acronym
- KIRMONO
- Status last verified
- Apr 2026
- First submitted
- 8 Oct 2010
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study on the Anti-tumor Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Fully Human Monoclonal Anti KIR Antibody, in Patients With Smoldering Multiple Myeloma (KIRMONO)
- ClinicalTrials.gov ID
- NCT01222286
- Acronym / sponsor ID
- KIRMONO / IPH2101-203
- Conditions
- Smoldering Multiple Myeloma
- Keywords
- Smoldering Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Innate PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Posted 9 May 2014
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 evaluate the anti-tumor activity, safety and pharmacology of two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma.
Detailed description
This is a randomized Phase II, open label, multi-centre study, with two independent arms.
Patients receive 6 injections of IPH2101, at the dose of 0.2 mg/kg or 2 mg/kg (according to their randomization) administered over one hour infusion at four weeks intervals.
A patient whose disease achieves at least a minimal response to study treatment at any time during the initial period of 6 cycles can be treated with an additional period of treatment of 6 cycles.
Patients are followed 6 months after treatment completion or until a KIR occupancy level < 30% (i.e if the time required for KIR desaturation was > 6 months), whichever is longer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPH2101 0.2 mg/kg | Experimental | Drug: IPH21010.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles |
| IPH2101 2 mg/kg | Experimental | Drug: IPH21012 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- SMM of any risk level according to a definition derived of the International Myeloma Working Group definition ( Br J Haematol 2003; 121: 749) : Serum M protein ≥ 3 g/dl , AND/OR Bone Marrow plasma cells ≥ 10 % with no evidence of end-organ damage (CRAB)
- Measurable disease defined as a disease with a serum M protein ≥ 1 g/dl
- No evidence of fatigue, recurrent infections or any clinical suspicion of MM
- Diagnosis of SMM confirmed on two consecutive assessments (ie fluctuation under 25% of serum protein level) performed with at least a 4 week interval.
- Age > 18 years or < 75 years
Key exclusion criteria (18 listed)
- Previous treatment having a proven or potential impact on myelomatous cells proliferation or survival (including IMiDs or proteasome inhibitors, conventional chemotherapies within the last 5 years, steroids within the last month prior to enrolment). Previous bisphosphonates started less than 3 months prior to enrolment.
- Use of any investigational agent within the last 3 months
- Clinical laboratory values at screening
- Primary or associated amyloidosis
- Abnormal cardiac status with any of the following
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: a human monoclonal anti-KIR antibody (1-7F9)0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles | Drug | IPH2101 0.2 mg/kg, IPH2101 2 mg/kg |
Primary outcome
Rate of Patients Achieving an Objective Response
Time frame: from start to end of study (14 months)
The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.
3 secondary outcomes
Safety Assessment
Time frame: Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
Pharmacodynamics of IPH2101
Time frame: from start to end of study (14 months)
Secondary Anti-tumor Activity
Time frame: from start to end of study (14 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- 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.
Nikhil Munshi, MD principal investigator
Dana-Farber Cancer Institute- Medical Oncology- Boston MA-USA
5 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 Smoldering Multiple Myeloma, run by Innate Pharma at 5 sites 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 12 inclusion and 18 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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 9 May 2014). 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 an Objective Response (time frame: from start to end of study (14 months)). 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 14 May 2026.