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An Open-label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

An Open-label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or 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 bortezomib and dexemethasone in 21 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 bortezomib and dexamethasone.

- (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 bortezomib and dexamethasone.

- 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 bortezomib, defined as not having a
minimum clinical response of MR for at least 2 months during the last treatment with
bortezomib.

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 bortezomib and dexamethasone

Outcome Description:

Frequency and intensity of adverse events and laboratory measurements

Outcome Time Frame:

Last patient Last treatment of Part 2 - 24 weeks after initiation of treatment.

Safety Issue:

Yes

Principal Investigator

Antonio Palumbo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hematology, University of Torino

Authority:

United States: Food and Drug Administration

Study ID:

GEN504

NCT ID:

NCT01620879

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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