Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Biological: Bortezomib; Biological: Lenalidomide; Biological: Dexamethasone; Biological: Anti-CXCR4 (BMS-936564)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01359657

CA212-002

Details and patient eligibility

About

The purpose of this study is to determine 1) the safety and tolerability of multiple intravenous doses of anti-CXCR4 (BMS-936564) as monotherapy and as combination, and 2) the maximum tolerated dose (MTD) of BMS-936564 in combination with Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in subjects with relapsed or refractory multiple myeloma.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Subjects must have confirmed diagnosis of multiple myeloma with measurable disease Excluded are subjects with only plasmacytomas, plasma cell leukemia, or non-secretory myeloma.
• Disease must be assessed within 28 days prior to treatment initiation.
• Subjects must have evidence of relapsed or relapsed/refractory disease.
• Subjects must have received at least 2 prior regimens for multiple myeloma.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2.
• Subjects must have received last treatment (ie, chemotherapy, radiotherapy, biological, immunotherapy or investigational agent [therapeutic or diagnostic]) at least 14 days prior to treatment initiation. The last treatment of systemically absorbed steroids must be at least 2 weeks or 5 half lives (whichever is shorter) before the first dose of BMS-936564.

Exclusion Criteria:

• A serious uncontrolled medical disorder or active infection.
• Current or recent (within 3 months) gastrointestinal disease or condition that could impact the absorption of orally-administered drug.
• Inability to swallow oral medication.
• Uncontrolled or significant heart disease.
• Any other malignancy, excluding basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Arm A: Anti-CXCR4 (BMS-936564)+Lenalidomide+Dexamethasone

Experimental group

Treatment:

Biological: Dexamethasone

Biological: Anti-CXCR4 (BMS-936564)

Biological: Dexamethasone

Biological: Anti-CXCR4 (BMS-936564)

Biological: Lenalidomide

Arm B: Anti-CXCR4 (BMS-936564)+Bortezomib+Dexamethasone

Experimental group

Treatment:

Biological: Dexamethasone

Biological: Anti-CXCR4 (BMS-936564)

Biological: Dexamethasone

Biological: Anti-CXCR4 (BMS-936564)

Biological: Bortezomib