Trials / Terminated
TerminatedNCT02952573
Testing JNJ-42756493 In Combination With Dexamethasone in Multiple Myeloma That Came Back After a Period of Improvement
A Phase II Open Label, Multicenter, Trial of JNJ-42756493 In Combination With Dexamethasone For The Treatment Of FGFR3 Wild-type Or Mutation Positive Relapsed and/or Refractory Multiple Myeloma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
Participants in the study will be assigned to one of two groups: One group of participants will be FGFR3 wild-type (participants whose tumors have no mutations or changes of a gene called FGFR3) and the other group will be FGFR3 mutated (participants whose tumors 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JNJ-42756493 | Once daily dosing |
| DRUG | Dexamethasone | Cycle 1 and 2: OD dosing on days 1-4, 9-12, and 17-20;Cycle 3: OD dosing on days 1, 8, 15, 22 |
Timeline
- Start date
- 2017-06-13
- Primary completion
- 2018-11-13
- Completion
- 2018-11-13
- First posted
- 2016-11-02
- Last updated
- 2020-09-17
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02952573. Inclusion in this directory is not an endorsement.