Plasma cell myeloma Non hodgkins lymphomas - follicular lymphoma, Mantle cell lymphoma, Lymphoplasmacytic lymphoma
Conditions
Interventions
Trade Name: Medrone
Product Name: Methylprednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: Methylprednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
Royal Devon and Exeter NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Patients with a previously established diagnosis of myeloma or lymphoma who are due to undergo peripheral blood stem cell mobilisation and harvesting as part of their routine care, ·WHO performance status of 0, 1 or 2, ·age > 18 years, ·signed consent form. 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
Exclusion criteria: ·Diabetes mellitus, ·a previous attempt at mobilising and harvesting PBSCs within 30 days from the intended beginning of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the addition of Methylprednisolone to the conventional stem cell mobilasation schedual of Cyclophosphamide and G-CSF will decrease the spread of days that the patient is ready for harvesting and therefore make the procedure more predictable.;Secondary Objective: Stem cell harvest yield and tolerability of the addtion of Methylprednisolone;Primary end point(s): Day post-mobilisation on which 1st PBSC harvest is carried out (the day of Cyclophosphamide administration will be taken as day 1; thus, a PBSC harvest undertaken on the 8th day after the beginning of stem cell mobilisation will be recorded as occurring on day 9). | — |
Countries
United Kingdom
Outcome results
None listed