NCT02573935

Brief Summary

This study evaluates the potential synergic anti-myeloma activity of clarithromycin when combined with VCD induction therapy in patients with newly diagnosed multiple myeloma.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

October 8, 2015

Last Update Submit

September 19, 2016

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaClarithromycinInduction ChemotherapyTransplantation, Autologous

Outcome Measures

Primary Outcomes (1)

  • Comparison of number of participants with very good partial response or better response after three courses of VCD combined with clarithromycin or placebo

    10 weeks

Secondary Outcomes (8)

  • 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

    Five months

  • Comparison of number of participants with sCR, CR, PR, PD or SD in the treatment groups after induction therapy and HDT, respectively

    Five months

  • Comparison of frequency of infections in patients treated VCD combined with clarithromycin or placebo

    9 weeks

  • Comparison of number of stem cells harvested in patients treated with clarithromycin and placebo in combination with VCD

    Three months

  • Neurotoxicity assessed by FACT/GOG-Ntx, Version 4.0

    Five months

  • +3 more secondary outcomes

Study Arms (2)

Clarithromycin

EXPERIMENTAL

Clarithromycin combined with VCD induction therapy

Drug: ClarithromycinDrug: VCD induction therapy

Placebo

PLACEBO COMPARATOR

Placebo combined with VCD induction therapy

Drug: PlaceboDrug: VCD induction therapy

Interventions

ClarithromycinDRUG

p.o. clarithromycin 500 mg twice daily for 63 days

Clarithromycin
PlaceboDRUG

Placebo tablet twice daily for 63 days

Placebo
VCD induction therapyDRUG

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)

ClarithromycinPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Myeloma diagnosis according to IMWG criteria
  • Treatment demanding disease
  • High-dose melphalan with stem cell support scheduled as a part of the treatment
  • Signed informed consent given prior to any study related activities
  • Age \> 18 years

You may not qualify if:

  • Allogeneic transplantation scheduled as a part of the treatment
  • Myeloma treatment prior to entry in the study, except radiotherapy, bisphosphonates/denosumab or corticosteroids for symptom control
  • Concurrent disease making clarithromycin treatment unsuitable
  • Positive pregnancy test (only applicable for women with childbearing potential)
  • Known or suspected hypersensitivity or intolerance to clarithromycin
  • 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 infarction 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 investigator, would make the patient inappropriate for entry into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Department of Hematology, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Department of Hematology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Department of Hematology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Hematology, Herlev Hospital

Herlev, 2730, Denmark

Location

Department of Hematology, Odense University Hospital

Odense, 5000, Denmark

Location

Department of Hematology, Roskilde Hospital

Roskilde, 4000, Denmark

Location

Department of Hematology, Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (3)

  • Gay F, Rajkumar SV, Coleman M, Kumar S, Mark T, Dispenzieri A, Pearse R, Gertz MA, Leonard J, Lacy MQ, Chen-Kiang S, Roy V, Jayabalan DS, Lust JA, Witzig TE, Fonseca R, Kyle RA, Greipp PR, Stewart AK, Niesvizky R. Clarithromycin (Biaxin)-lenalidomide-low-dose dexamethasone (BiRd) versus lenalidomide-low-dose dexamethasone (Rd) for newly diagnosed myeloma. Am J Hematol. 2010 Sep;85(9):664-9. doi: 10.1002/ajh.21777.

    PMID: 20645430BACKGROUND

  • Nielsen LK, Klausen TW, Jarden M, Frederiksen H, Vangsted AJ, Do T, Kristensen IB, Frolund UC, Andersen CL, Abildgaard N, Gregersen H. Clarithromycin added to bortezomib-cyclophosphamide-dexamethasone impairs health-related quality of life in multiple myeloma patients. Eur J Haematol. 2019 Jan;102(1):70-78. doi: 10.1111/ejh.13175. Epub 2018 Oct 29.

    PMID: 30230047DERIVED

  • Gregersen H, Do T, Kristensen IB, Frolund UC, Andersen NF, Nielsen LK, Andersen CL, Klausen TW, Vangsted AJ, Abildgaard N. A randomized placebo-controlled phase II study of clarithromycin or placebo combined with VCD induction therapy prior to high-dose melphalan with stem cell support in patients with newly diagnosed multiple myeloma. Exp Hematol Oncol. 2018 Aug 13;7:18. doi: 10.1186/s40164-018-0110-0. eCollection 2018.

    PMID: 30123673DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Henrik Gregersen, MD

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 12, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 20, 2016

Record last verified: 2016-09

Locations

DK(7)