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

• Conditions: Multiple Myeloma .

• Registration Number: EUCTR2006-000891-34-BE
• Lead Sponsor: Hôpital Ambroise Paré

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-03
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified