Testing JNJ-42756493 In Combination With Dexamethasone in Multiple Myeloma That Came Back After a Period of Improvement

Official Title

A Phase II Open Label, Multicentre, Trial of JNJ-42756493 In Combination With Dexamethasone For The Treatment Of FGFR3 Wild-type Or Mutation Positive Relapsed and/or Refractory Multiple Myeloma


This is a phase 2 study to see how effective investigational drug, JNJ-42756493, is when given in combination with dexamethasone in two groups of patients with multiple myeloma (cancer of the plasma cells, a type of white blood cell present in bone marrow) that has relapsed (has come back after a period of improvement) or refractory (did not respond to standard treatment).

Trial Description

Primary Outcome:

  • Objective response rate (ORR)
  • Minimal response rate
  • Stable disease rate
Secondary Outcome:
  • Incidence of toxicities
  • Progression free survival rate
  • Duration of response rate
Participants in the study will be assigned to one of two groups: One group of participants will be FGFR3 wild-type (participants whose tumours have no mutations or changes of a gene called FGFR3) and the other group will be FGFR3 mutated (participants whose tumours have mutations of FGFR3). Participants will receive JNJ-42756493 with dexamethasone for as long as their diseases do not progress (worsen) and they do not experience unacceptable side effects for a maximum of 24 cycles (approximately 22 months). While on the study drugs, participants will be asked to visit the clinic about 2 times during Cycles 1 and 2 and once during Cycle 3 and subsequent cycles for tests and procedures.

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society