A randomized, international, open-label, phase II study of peripheral blood progenitor cell (PBPC) mobilization and engraftment with pegfilgrastim or filgrastim for autologous transplantation in subjects with multiple myeloma. - NeuMobil

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2006-000891-34-BE
• Date of registration: 03/03/2006
• Prospective Registration: Yes
• Primary sponsor: Hôpital Ambroise Paré
• Public title: A randomized, international, open-label, phase II study of peripheral blood progenitor cell (PBPC) mobilization and engraftment with pegfilgrastim or filgrastim for autologous transplantation in subjects with multiple myeloma. - NeuMobil
• Scientific title: A randomized, international, open-label, phase II study of peripheral blood progenitor cell (PBPC) mobilization and engraftment with pegfilgrastim or filgrastim for autologous transplantation in subjects with multiple myeloma. - NeuMobil
• Date of first enrolment: 05/05/2006
• Target sample size: 110
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000891-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
• Subject achieving complete, partial or minimal response according to Bladé criteria (see Annex A) after 4 cycles of induction first line chemotherapy (VAD or Thal/Dex or Vel/Dex or VTD or any other induction chemotherapy) (response evaluation will be performed after finalization of 3rd or 4th VAd or between cycle 3 and 4 of Thal/Dex or between cycle 3 and 4 of Vel/Dex or between cycle 3 and 4 of VTD)
• Aged 18-70 years
• Subject has given voluntary written informed consent
• Subject is in the investigator’s opinion, willing and able to comply with the protocol requirements
• Subject has an ECOG < 3
• Subject has the following laboratory values at baseline:
• Platelet count = 50x109/L without transfusion support within 7 days before the laboratory test
• Absolute neutrophil count (ANC) =1000 without the use of colony stimulating factors
• Corrected serum calcium < 14 mg/dl
• Aspartate transaminase (AST) = 2.5xULN
• Alanine transaminase (ALT) = 2.5xULN
• Total bilirubin = 1.5xULN
• Male or female subject who is post-menopausal, surgically sterilized or willing to use an acceptable method of birth control for the duration of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Subject receiving colony stimulating factors
• Subject underwent plasmapheresis within 4 weeks before enrolment
• Subject had major surgery within 4 weeks before enrolment
• Subject with amyloidosis
• Subject with myocardial infarction within 6 months prior enrolment or with NHYA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• Subject treated for a cancer other than MM within 5 years before randomization (except basal cell carcinoma or in situ cervical uterine carcinoma)
• Subject has another serious medical condition that could potentially interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery.
• Compromised renal function as evidenced by measured or calculated creatinine clearance = 50 ml/min
• Sero-positive for HIV antibody
• Subject known to be hepatitis B surface antigen positive or who has an active hepatitis C infection
• Subject has an active systemic infection requiring treatment
• Female subject is pregnant or breast feeding
• Subject enrolled in another clinical trial and/or receiving an investigational agent that will contra-indicate the use of pegfilgrastim as either mobilization agent or hematological recovery agent. Subjects are allowed to simultaneously participate to non-investigational trials.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multiple Myeloma .

Intervention(s)

Product Name: Neupogen 30
Pharmaceutical Form: Injection*
INN or Proposed INN: Filgrastim
CAS Number: 121181-53-1
Current Sponsor code: 2006-000891-34
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.600-

Product Name: Neupogen 48
Pharmaceutical Form: Injection*
INN or Proposed INN: Filgrastim
CAS Number: 121181-53-1
Current Sponsor code: 2006-000891-34
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.960-

Product Name: Neulasta
Pharmaceutical Form: Injection*
INN or Proposed INN: PegFilgrastim
CAS Number: 208265-92-3
Current Sponsor code: 2006-000891-34
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-

Primary Outcome(s)

Main Objective: To evaluate engraftment of PBPC’s mobilized by two different fixed doses of pegfilgrastim and a by-weight dose of filgrastim

Secondary Objective: Assess the ability of two different fixed doses of pegfilgrastim to mobilize PBPC.
Assess the safety of pegfilgrastim
Assess VAD,Thal/Dex, Vel/Dex and VTD or any induction chemotherapy on autologous transplantation
The following endpoints will be analysed overall and by induction chemotherapy type:
Evaluate the CD34+ cells/kg yield in each leukapheresis
Evaluate the number of leukaphereses to collect 2x106 CD34+ cells/kg and 4x106 CD34+ cells/kg
Evaluate the proportion of subjects with platelet recovery = 20x109/L in the absence of transfusion for at least 7 days
Evaluate the proportion of subjects with ANC recovery of = 0.5x109/L
Evaluate the time to ANC 0.5x109/L for 3 consecutive days
Evaluate the time to ANC 1.0x109/L
Evaluate the time to platelet recovery (time to platelets = 20x109/L in the absence of platelet transfusion support for at least 7 days)
Evaluate the incidence and duration of hospitalization during mobilization phase and during post-transplant phase

Primary end point(s): Number of subjects with engraftment of PBPC mobilized by two different doses of pegfilgrastim (12 mg and 18 mg) given as a single administration compared to a standard daily by-weight dose of filgrastim (10µg/kg) after induction chemotherapy (VAD, Thal/Dex, Vel/Dex, VTD or any other induction chemotherapy) in subjects with multiple myeloma.
Engraftment is defined as an ANC recovery of = 0.5x109/L for 3 consecutive days and a platelet recovery of = 20x109/L in the absence of platelet transfusion within 7 days. If a tandem transplant is planned, only the first transplantation will be assessed.

Secondary ID(s)

ERA2006001