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Anti-CXCR4

Phase 1

Multiple Myeloma | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Trials Updated: Mar 16, 2016

Anti-CXCR4 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2011

Anti-CXCR4 target and mechanism

ModalityMonoclonal antibody

Also known as Anti-CXCR4 (BMS-936564)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Anti-CXCR4 clinical trials

Anti-CXCR4 · 1 trial · 1 indication

Phase 1 1
NCT01359657Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple MyelomaMultiple Myeloma
COMPLETED46 Analytics
PHASE1COMPLETED
Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Determination of maximum tolerated dose
42 days in Arm A

Secondary Endpoints

Safety and tolerability will be analyzed for all patients. Safety endpoints will be based on adverse event reports, and include frequent adverse event (AE)s, serious adverse event (SAE)s and lab abnormalities
Safety will be evaluated up to 2 years
Pharmacokinetic (PK) measures will be collected for all patients who received study medication. The pharmacokinetic parameters will be maximum observed concentration (Cmax)
PK samples will be collected multiple time points during Cycle 1 (Arm A is Day 1-42, Arm B is Day 1-35). In Cycle 2 samples will be collected on days 1, 8 & 15, at end of treatment & during the follow-up visit. Similar PK sampling will occur in Arm A & B
Pharmacokinetic (PK) measures will be collected for all patients who received study medication. The pharmacokinetic parameters will be trough observed concentration (Cmin)
PK samples will be collected multiple time points during Cycle 1 (Arm A is Day 1-42, Arm B is Day 1-35). In Cycle 2 samples will be collected on days 1, 8 & 15, at end of treatment & during the follow-up visit. Similar PK sampling will occur in Arm A & B
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A: Anti-CXCR4 (BMS-936564)+Lenalidomide+DexamethasoneEXPERIMENTAL -
Arm B: Anti-CXCR4 (BMS-936564)+Bortezomib+DexamethasoneEXPERIMENTAL -

Interventions

NameTypeDescription
Anti-CXCR4 (BMS-936564)BIOLOGICALSolution, Intravenously, 1-10 mg/kg, Single 60 minute infusion once a week, 42 days (cycle 1) 28 days subsequent cycles
LenalidomideBIOLOGICALTablets, per os (by mouth route of administration) (P.O), 25 mg, daily for 21 days (Day 15-35 in cycle 1; Day 1-21 in subsequent cycles), no dosing in Cycle 1, Cycle 2 +:daily dosing from Day 1-21
DexamethasoneBIOLOGICALTablets, per os (by mouth route of administration) (P.O), 40 mg, administered with Lenalidomide once every 7 days, 42 days (cycle 1) 28 days subsequent cycles
BortezomibBIOLOGICALIntravenous (IV), 1.3 mg/m2, administered on day 15, 18, 22, 25 in cycle 1, then on Day 1, 4, 8, 11 in subsequent cycles, no dosing in Cycle 1, Cycle 2 +:dosing on Day 1, 4, 8, 11
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 myel...

Countries:United States
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Competitive Landscape -Multiple Myeloma 338 trials

Frequently asked questions about Anti-CXCR4

What is Anti-CXCR4 used for?

Anti-CXCR4 is an investigational monoclonal antibody being studied for the treatment of multiple myeloma, a cancer of plasma cells in the bone marrow. It was evaluated in patients with relapsed or refractory multiple myeloma, both as a single agent and in combination with other therapies. It is not approved for any indication.

What does Anti-CXCR4 target?

Anti-CXCR4 targets the CXCR4 receptor, a chemokine receptor that is a monoclonal antibody. By binding to CXCR4, the drug is designed to block signaling through this receptor, which is involved in the trafficking and retention of myeloma cells in the bone marrow microenvironment.

Who is developing Anti-CXCR4?

Anti-CXCR4 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company sponsored the clinical trial that evaluated the drug in multiple myeloma.

What phase is Anti-CXCR4 in?

Anti-CXCR4 is in Phase 1 clinical development. It has completed one Phase 1 trial in relapsed or refractory multiple myeloma. The drug remains investigational and has not been approved by the FDA for any indication.

What clinical trials is Anti-CXCR4 in?

Anti-CXCR4 has been studied in one completed Phase 1 trial, NCT01359657, titled Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma. The trial enrolled 46 patients in the United States and is no longer active.

Is Anti-CXCR4 the same as BMS-936564?

Yes, Anti-CXCR4 is also known as BMS-936564. The two names refer to the same investigational monoclonal antibody developed by Bristol-Myers Squibb. BMS-936564 is the company's internal designation for the anti-CXCR4 antibody.