Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.

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Detailed Description

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Patients who have relapsed myeloma have failed treatment regimens and have had disease progression following their last treatment regimen. Despite newer salvage therapies, their treatment options are limited and may include best supportive care and investigational therapy. Patients with plateau-phase myeloma have a stabilized serum M-protein level without further tumor regression despite continued treatment. Recent evidence suggests that their prognosis might improve with further reduction in serum M-protein or prolongation of time to disease progression (TTP). These patients are candidates for investigational agents that could further reduce tumor burden or increase TTP.

Conditions

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Relapsed or Plateau-Phase 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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Denosumab

Group Type EXPERIMENTAL

DENOSUMAB

Intervention Type DRUG

120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each.

Interventions

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DENOSUMAB

120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years
* clinical diagnosis of relapsed or plateau-phase multiple myeloma
* measurable disease (\>0.5 g/dL) as determined by special blood tests
* ECOG 0 or 1

Exclusion Criteria

* newly diagnosed myeloma
* non-secretory myeloma
* plasma cell leukemia or plasma cell dyscrasia with POEMS syndrome
* prior allogeneic stem cell transplant
* administration of oral or IV bisphosphonates within 2 weeks of enrollment to study

Other criteria also apply.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No