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

Summary:

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

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society