CP-751,871 Treatment For Patients With Multiple Myeloma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2008-06-30

Brief Summary

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This study represents the first-in-human study for CP-751,871. The study aimed to define the safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple myeloma through a dose escalation design.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single agent CP-751,871

dose escalation design

Group Type EXPERIMENTAL

CP-751,871

Intervention Type DRUG

CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability

Interventions

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CP-751,871

CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previously treated multiple myeloma with a quantifiable serum (M spike ≥ 1 g/dL) and/or urine (≥ 200 mg/24-hr) paraprotein
* Adequate bone marrow, renal, liver and cardiac function
* Eastern Cooperative Oncology Group \[ECOG\] performance status less than or equal to 2

Exclusion Criteria

* Prior allogeneic stem cell transplant (alloSCT)
* Myelosuppressive chemotherapy or immunotherapy within 3 weeks prior to treatment with CP-751,871
* Prior organ allograft
* Concurrent use of insulin, oral hypoglycemic medication, growth hormone (GH), or growth hormone inhibitors
* Female patients who are pregnant or lactating

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No