A Phase 2 interventional study of Clarithromycin and Placebo in Multiple Myeloma, sponsored by Henrik Gregersen. Terminated at 7 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-20.
Sponsored by Henrik Gregersen · Phase 2, Interventional, and Treatment
This study evaluates the potential synergic anti-myeloma activity of clarithromycin when combined with VCD induction therapy in patients with newly diagnosed multiple myeloma.
The survival in younger myeloma patients improved in the nineties with the introduction of high-dose melphalan with autologous stem cell support (HDT). However, all patients will eventually experience relapse after HDT and there is a need for improvement of the response after HDT. The choice of induction treatment before HDT affects the outcome after induction therapy as well as the outcome after HDT.
Clarithromycin is a macrolide antibiotic frequently utilized in the treatment of respiratory tract infections and is often used in patients with known hypersensitivity to beta-lactam antibiotic. Besides antibiotic activity, clarithromycin may exert immunomodulatory and anti-inflammatory effects. The toxicity profile of clarithromycin is favourable and the cost is very low.
Studies on cell lines have shown that clarithromycin attenuates autophagy in myeloma cells and a recent study has demonstrated that treatment with clarithromycin enhanced bortezomib-induced cytotoxicity in myeloma cells. Phase II studies without control groups have indicated that clarithromycin might enhance the effect of the thalidomide and lenalidomide. A case-matched analysis compared patients at one centre receiving clarithromycin, lenalidomide and dexamethasone with an equal number of patients at another centre receiving lenalidomide and dexamethasone. This study indicated a favourable effect of clarithromycin with a higher frequency of complete response, very-good-partial-response or better response and progression-free survival. However, there is a need for controlled studies to determine whether clarithromycin might enhance the effect of other myeloma agents.
This randomized placebo-controlled study will include 160 patients with newly diagnosed multiple myeloma eligible for HDT. The study evaluates the potential synergic anti-myeloma activity of clarithromycin when combined with VCD induction therapy in patients with newly diagnosed multiple myeloma, and is conducted by the Danish Myeloma Study Group (DMSG) at seven clinics in Denmark. The first patient was included in May 2015 and enrolment is expected to continue until October 2016. The study ends when the last included patient has been followed for two months after HDT.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 58 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Henrik Gregersen is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clarithromycin combined with VCD induction therapy
Drug: Clarithromycin · Drug: VCD induction therapy
Placebo combined with VCD induction therapy
Drug: Placebo · Drug: VCD induction therapy
p.o. clarithromycin 500 mg twice daily for 63 days
Placebo tablet twice daily for 63 days
Three courses of VCD (sc bortezomib 1.3 mg/sqm days 1, 4, 8, 11, iv cyclophosphamide 500 mg/sqm on days 1 and 8, and p.o. dexamethasone 40 mg days 1, 2, 4, 5, 8, 9, 11, 12 in each 21-days course)
Comparison of number of participants with very good partial response or better response after three courses of VCD combined with clarithromycin or placebo
Time frame: 10 weeks
Comparison of number of participants with very good partial response or better response after HDT in patients treated with three courses of VCD combined with clarithromycin or placebo
Time frame: Five months
Comparison of number of participants with sCR, CR, PR, PD or SD in the treatment groups after induction therapy and HDT, respectively
Time frame: Five months
Comparison of frequency of infections in patients treated VCD combined with clarithromycin or placebo
Time frame: 9 weeks
Comparison of number of stem cells harvested in patients treated with clarithromycin and placebo in combination with VCD
Time frame: Three months
Neurotoxicity assessed by FACT/GOG-Ntx, Version 4.0
Time frame: Five months
Quality of life assessed by EORTC QLQ-MY20
Time frame: Five months
Quality of life assessed by EORTC QLQ-C30
Time frame: Five months
Comparison of adverse events in patients treated VCD combined with clarithromycin or placebo assessed by CTCAE v4.0
Time frame: Three months
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Henrik Gregersen