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Phase 1 Multiple Ascending Dose Study of Elotuzumab (BMS-901608) in Combination With Lenalidomide/Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan


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

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Trial Information

Phase 1 Multiple Ascending Dose Study of Elotuzumab (BMS-901608) in Combination With Lenalidomide/Low-dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan


Inclusion Criteria:



- Received between 1 to 4 prior lines of therapy

- Measureable disease

- Men and women of childbearing potential (WOCBP) must be using two acceptable methods
of contraception

- Men must agree to use a latex condom and a second form of birth control during sexual
contact with WOCBP and must agree to not donate semen during study drug therapy

- Subjects must be willing to refrain from blood donations during study drug therapy

Exclusion Criteria:

- Subjects with non-secretory or oligo-secretory or light-chain only myeloma or
active/prior plasma cell leukemia or known /suspect POEMS syndrome

- Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
cell dyscrasia

- Unable to take aspirin daily as prophylactic anticoagulation therapy. Prior history
of inability to tolerate weekly 40 mg dexamethasone

- History of renal failure

- History of clinical significant thrombosis, such as treatment for thrombosis was
required

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of safety and tolerability of Elotuzumab in combination with Lenalidomide and low dose Dexamethasone, based on the assessment of the Dose Limiting Toxicity (DLT) expression

Outcome Time Frame:

Within the first 28 days

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

CA204-005

NCT ID:

NCT01241292

Start Date:

February 2011

Completion Date:

September 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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