A Study Evaluating the Activity, Safety and Pharmacology of Two Doses of IPH2101, a Human Monoclonal Anti-KIR Antibody, in Patients With Multiple Myeloma in Stable Partial Response After a First Line Therapy

Multiple Myeloma Clinical Trial

— REMYKIR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999830
• Other study ID #: IPH2101-201
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2009
• Last updated: August 8, 2013
• Start date: September 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Innate Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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).

Other known NCT identifiers

• NCT01937741

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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)

3. 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;

• 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.

4. ECOG performance status of 0, 1 or 2.

5. 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

6. 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.

7. Signed inform consent obtained before any trial-related activities

Exclusion Criteria:

1. Age < 18 years old or > 75 years old

2. Previous consolidation/ maintenance therapy by Imid (thalidomide, lenalidomid) or bortezomib within the last 2 months

3. Treatment with chemotherapy, systemic corticosteroid within the previous 2 months

4. Treatment with growth factors (EPO, G- or GM-CSF) within the previous 1 month

5. Radiotherapy for bone or visceral lesion within the last 3 months

6. Use of any investigational agent within the last 2 months

7. Primary or associated amyloidosis

8. Peripheral neuropathy of grade = III according to the CTCAE of the NCI

9. Abnormal cardiac status with any of the following

1. NYHA stage III or IV congestive heart failure

2. myocardial infarction within the previous 6 months

3. symptomatic cardiac arrhythmia despite treatment

10. Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen

11. History of or current auto-immune disease

12. Serious concurrent uncontrolled medical disorder

13. History of other malignancy for less then 5 years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma)

14. History of allogenic hematopoietic cell or solid organ transplantation

15. Pregnant or lactating women

16. Any medical condition which is regarded by the investigator as incompatible with the study participation

17. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• IPH2101 Fully human anti-KIR monoclonal antibody
One infusion of IPH2101 every 4 weeks

Locations

Country	Name	City	State
France	C.H.R.U. de Caen - Hôpital Bretonneau	Caen
France	CHU Dijon	Dijon
France	CHRU Lille	Lille
France	Hôpital Dupuytren	Limoges
France	Institut Paoli Calmettes	Marseille
France	CHU Nancy	Nancy
France	CHRU Nantes	Nantes
France	Hôpital Saint Antoine	Paris
France	Hopital Saint Louis	Paris
France	Hopital Purpan	Toulouse
France	C.H.R.U. de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Innate Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	M-protein will be measured in serum at Screening and every 4 weeks during the study period from Cycle1-day1 to End of Study		every 4 weeks	No
Secondary	To assess pharmacokinetic (PK) parameters of Anti-KIR		every 4 weeks	No
Secondary	To assess pharmacodynamic parameters of Anti-KIR		every 4 weeks	No
Secondary	To assess Safety of 2 dose regimens of Anti-Kir		every 4 weeks	Yes