Patients With Multiple Myeloma Experiencing aPhase 1KIRIMIDNCT01217203
Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101 Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse
A Phase 1 study testing IPH2101 combined to lenalidomide in people with Patients With Multiple Myeloma Experiencing a and First or Second Relapse, run by Innate Pharma at 6 sites in United States.
Trial summary
The primary objective of the clinical study is to evaluate, in patients who experience a first or second relapse of their multiple myeloma, the safety of escalating doses of IPH2101 combined with lenalidomide Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients With Multiple Myeloma Experiencing a, First or Second Relapse
- What is being tested?
- IPH2101 combined to lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2010to Feb 2014
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained before any trial-related activities
- Progressive disease or relapse of multiple myeloma (according to the IMWG definition) after one or two prior therapeutic treatments or regimens for multiple myeloma that achieved a response duration of at least 6 months
- Prior therapeutic treatment regimens may have included Thalidomide and Lenalidomide. Regarding patients previously treated by Lenalidomide, only patients who achieved at least Partial Response duration of at least 6 months can be included. The patient must not have discontinued treatment due to Lenalidomide intolerance.
- Measurable disease, as indicated by one or more of the following:
- Serum M-protein ≥ 0.5 g/dL If Serum Protein Electrophoresis is felt to be unreliable for routine M-protein measurement (particularly for patients with IgA MM), then quantitative immunoglobulin levels can be accepted).
- Urine Bence-Jones protein ≥ 200 mg/24 h
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- Involved serum Free Light Chains (sFLC) level ≥ 10 mg/dl ( ≥ 100 mg/l) provided sFLC ratio is abnormal (<0.26 or >1.65)
- ECOG performance status of 0, 1 or 2
- Clinical laboratory values at screening
- Calculated creatinine clearance (according to MDRD) > 60 ml/min
- Platelet ≥ 75 x 109 /l for patients with < 50% BM plasma cells, and ≥ 30 x 109 /l for patients with > 50% BM plasma cells
- ANC > 1 x 109 /l
- Bilirubin levels < 1.5 ULN ; ALT and AST < 3 ULN (grade 1 NCI)
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing Lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking Lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Who cannot join
- Age < 18 years or > 80 years
- Non secreting multiple myeloma or non measurable disease (< 0.5 g /dL M-Protein in serum or < 200 mg urinary M-protein / 24 h or <10 mg/dl involved sFLC)
- Life-threatening conditions related or not to MM relapse
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking Lenalidomide)
- Known hypersensitivity to thalidomide or IMiD®.
- Use of any investigational agent within the last month
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- Treatment by systemic corticosteroids (except inhaled corticosteroids) or chemotherapy (including consolidation and maintenance) within the last month (use of biphosphonates is permitted)
- Radiotherapy within the last month
- Primary or associated amyloidosis
- Peripheral neuropathy of grade ≥ 3 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
- cardiac arrhythmia remaining symptomatic despite 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 5 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
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Inability to comply with an antithrombotic regimen
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dana Farber
Boston, Massachusetts, 02115
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Saint Francis Hospital
Greensville, South Carolina, 29601
NYU Clinical Cancer Center
New York, New York, 10016
Mount Sinai Medical Center
New York, New York, 10029
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Multicenter Phase I Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101, a Human Monoclonal Anti-KIR, Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse
The primary objective of the clinical study is to evaluate, in patients who experience a first or second relapse of their multiple myeloma, the safety of escalating doses of IPH2101 combined with lenalidomide
- Being tested
- IPH2101 combined to lenalidomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPH2101 combined to lenalidomideDrug
Dose level 1 : 0.2 mg/kg IPH2101(with Lenalidomide 10 mg/day) Dose level 2 : 0.2 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 3 : 1 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 4 : 2 mg/kg IPH2101(with Lenalidomide 25 mg/day)
Extension cohort: 6 patients at the Maximum Tolerated Dose (MTD)
| Study group | Role | What they receive |
|---|---|---|
| IPH2101 and lenalinomide | Experimental | Not described Receives: Drug: IPH2101 combined to lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with Dose Limiting Toxicity (DLT) at each dose level
safety of IPH2101 combined with lenalidomide at different dose levels.
Measured: 1 year
Secondary outcomes (1)
To assess response rate of the combination
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 posted8 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Multiple Myeloma Experiencing aStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innate Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Don Benson, MD, Principal investigator, The Ohio State University Comprehensive Cancer Center - Columbus OH - USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217203
- Sponsor's protocol ID
- IPH2101-202
- Acronym
- KIRIMID
- Status last verified
- Feb 2014
- First submitted
- 6 Oct 2010
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Benson DM Jr, Cohen AD, Jagannath S, Munshi NC, Spitzer G, Hofmeister CC, Efebera YA, Andre P, Zerbib R, Caligiuri MA. A Phase I Trial of the Anti-KIR Antibody IPH2101 and Lenalidomide in Patients with Relapsed/Refractory Multiple Myeloma. Clin Cancer Res. 2015 Sep 15;21(18):4055-61. doi: 10.1158/1078-0432.CCR-15-0304. Epub 2015 May 21.
PubMed 25999435
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase I Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101, a Human Monoclonal Anti-KIR, Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse
- ClinicalTrials.gov ID
- NCT01217203
- Acronym / sponsor ID
- KIRIMID / IPH2101-202
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Innate PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Oct 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 primary objective of the clinical study is to evaluate, in patients who experience a first or second relapse of their multiple myeloma, the safety of escalating doses of IPH2101 combined with lenalidomide
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPH2101 and lenalinomide | Experimental | Drug: IPH2101 combined to lenalidomide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed informed consent obtained before any trial-related activities
- Progressive disease or relapse of multiple myeloma (according to the IMWG definition) after one or two prior therapeutic treatments or regimens for multiple myeloma that achieved a response duration of at least 6 months
- Prior therapeutic treatment regimens may have included Thalidomide and Lenalidomide. Regarding patients previously treated by Lenalidomide, only patients who achieved at least Partial Response duration of at least 6 months can be included. The patient must not have discontinued treatment due to Lenalidomide intolerance.
- Measurable disease, as indicated by one or more of the following:
- ECOG performance status of 0, 1 or 2
Key exclusion criteria (21 listed)
- Age < 18 years or > 80 years
- Non secreting multiple myeloma or non measurable disease (< 0.5 g /dL M-Protein in serum or < 200 mg urinary M-protein / 24 h or <10 mg/dl involved sFLC)
- Life-threatening conditions related or not to MM relapse
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking Lenalidomide)
- Known hypersensitivity to thalidomide or IMiD®.
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 |
|---|---|---|
| IPH2101 combined to lenalidomideDose level 1 : 0.2 mg/kg IPH2101(with Lenalidomide 10 mg/day) Dose level 2 : 0.2 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 3 : 1 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 4 : 2 mg/kg IPH2101(with Lenalidomide 25 mg/day) Extension cohort: 6 patients at the Maximum Tolerated Dose (MTD) | Drug | IPH2101 and lenalinomide |
Primary outcome
number of patients with Dose Limiting Toxicity (DLT) at each dose level
Time frame: 1 year
safety of IPH2101 combined with lenalidomide at different dose levels.
1 secondary outcome
To assess response rate of the combination
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 28 Feb 2014.
- Derived from this study: PubMed 25999435Benson DM Jr, Cohen AD, Jagannath S, Munshi NC, Spitzer G, Hofmeister CC, Efebera YA, Andre P, Zerbib R, Caligiuri MA. A Phase I Trial of the Anti-KIR Antibody IPH2101 and Lenalidomide in Patients with Relapsed/Refractory Multiple Myeloma. Clin Cancer Res. 2015 Sep 15;21(18):4055-61. doi: 10.1158/1078-0432.CCR-15-0304. Epub 2015 May 21.
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.
Don Benson, MD principal investigator
The Ohio State University Comprehensive Cancer Center - Columbus OH - USA
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPH2101 combined to lenalidomide in people with Patients With Multiple Myeloma Experiencing a and First or Second Relapse, run by Innate Pharma at 6 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 15 inclusion and 21 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 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 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.
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?
number of patients with Dose Limiting Toxicity (DLT) at each dose level (time frame: 1 year). 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 NCT01217203, which also lists 1 linked publication.
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 2014.