An Open Label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
18 Years
N/A
Both
Multiple Myeloma
Trial Information
An Open Label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
The study is conducted in two parts. The dose escalation portion of the trial (Part 1)
subjects are enrolled into cohorts at increasing dose levels of daratumumab in combination
with Len/Dex in 28 day treatment cycles. Part 2, the cohort expansion part of the trial,
will further explore the maximum tolerated dose (MTD) (or the maximum tested dose) of
daratumumab as determined in Part 1.
Inclusion Criteria:
- (Part 1) Have MM after receiving a minimum of 2 and a maximum of 4 prior lines of
therapy and be eligible for treatment with Len/Dex.
- (Part 2) Have relapsed MM after receiving a minimum of 1 and a maximum of 3 prior
lines of therapy, and be eligible for treatment with Len/Dex.
- Be older than or be 18 years of age.
- ECOG performance status (0-2).
- Following receipt of verbal and written information about the study, the patient must
provide signed informed consent before any study related activity is carried out.
Exclusion Criteria:
- Have previously received an allogenic stem cell transplant.
- Have received autologous stem cell transplant within 12 weeks before the first
infusion.
- Have received chemotherapy or any experimental drug or therapy within 3 weeks before
the first infusion.
- Have received bortezomib, lenalidomide, or thalidomide within 2 weeks before the
first infusion.
- Have multiple myeloma that is refractory to lenalidomide, defined as not having a
minimum clinical response of MR for at least 2 months during the last treatment with
lenalidomide).
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Establish the safety profile of daratumumab when given in combination with Len/Dex
Outcome Time Frame:
Last patient Last treatment of Part 2 - maximum 24 cycles (approximately 2 years) or until progression.
Safety Issue:
Yes
Principal Investigator
Torben Plesner, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vejle Hospital
Authority:
United States: Food and Drug Administration
Study ID:
GEN503
NCT ID:
NCT01615029
Start Date:
June 2012
Completion Date:
August 2015
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
