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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

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 InstituteBoston, Massachusetts  02115