multiple myeloma
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE PROPIONATE
CAS Number: 15423-89-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10 -
Trade Name: v
Sponsors
Danish Myeloma Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Myeloma diagnosis according to IMWG criteria • Treatment demanding disease • High-dose melphalan with stem cell support scheduled as a part of the treat-ment • Signed informed consent given prior to any study related activities • Age > 18 years 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: • Allogeneic transplantation scheduled as a part of the treatment • Myeloma treatment prior to entry in the study, except radiotherapy, bisphos-phonates/denusumab or corticosteroids for symptom control • Concurrent disease making clarithromycin treatment unsuitable • Positive pregnancy test (only applicable for women with childbearing poten-tial) • Known or suspected hypersensitivity or intolerance to claritromycin • Prolonged QT corrected (QTc) interval ( > 500 msec on screening ECG) • Concurrent treatment with cabergoline, fluconazole, ketoconazole, pimozide, quetiapine, sirolimus, verapamil, tacrolimus, ergot alkaloid, simvastatin or other statins • Uncontrolled or severe cardiovascular disease including myocardial infarc-tion within 6 months of enrolment, uncontrolled angina or known cardiac amyloidosis • Severe renal dysfunction (estimated creatinine clearance <10 mL/min) • Serious medical or psychiatric illness which, in the judgment of the investi-gator, would make the patient inappropriate for entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of our study is to evaluate the effect of clarithromycin in combination with VCD induction therapy in patients with newly diagnosed multiple myeloma;Secondary Objective: • To compare very good partial response or better response two months after HDT in patients treated with three courses of VCD combined with clarithromycin or placebo • To assess other markers of effect in the treatment groups after induction therapy and HDT, respectively • To compare the frequency of infections in patients treated VCD combined with clarithromycin or placebo • To compare number of stem cells harvested in patients treated with clarithromycin and placebo in combination with VCD • To assess the tolerability of clarithromycin combined with VCD in patients with newly diagnosed multiple myeloma • To assess neurotoxicity • To assess quality of life ;Primary end point(s): • To compare very good partial response or better response after three courses of VCD combined with clarithromycin or pla-cebo;Timepoint(s) of evaluation of this end point: 2 and 5 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To compare very good partial response or better response two months after HDT in patients treated with three courses of VCD combined with clarithromycin or placebo • To assess other markers of effect in the treatment groups after induction therapy and HDT, respectively • To compare the frequency of infections in patients treated VCD combined with clarithromycin or placebo • To compare number of stem cells harvested in patients treated with clarithromycin and placebo in combination with VCD • To assess the tolerability of clarithromycin combined with VCD in patients with newly diagnosed multiple myeloma • To assess neurotoxicity • To assess quality of life ;Timepoint(s) of evaluation of this end point: 2 and 5 months | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Unit Hematology
Danish Myeloma Study Group
Outcome results
None listed