Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2010-11-30

Brief Summary

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RATIONALE: Some cancers need growth factors which are made by the body's white blood cells to keep growing.Anakinra may interfere with the growth factor and stop multiple myeloma from growing. Dexamethasone may stop cancer cells from growing. Giving anakinra together with dexamethasone may be an effective treatment for multiple myeloma.

PURPOSE: This phase II trial is studying how well anakinra works when given with or without dexamethasone in treating patients with smoldering myeloma or indolent multiple myeloma.

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Detailed Description

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OBJECTIVES:

Primary

\* Determine the response rate in patients with smoldering or indolent multiple myeloma treated with anakinra.

Secondary

* Determine the toxicity of anakinra alone or in combination with dexamethasone in these patients.
* Evaluate the response rate in patients treated with anakinra in combination with dexamethasone.
* Evaluate the proportion of patients who are progression-free at 6 months.
* Determine the tolerability of anakinra in combination with dexamethasone in these patients.
* Determine the time to progression to active multiple myeloma in patients treated with anakinra alone or in combination with dexamethasone.
* Assess the duration of response in these patients.

OUTLINE:

* Induction therapy: Patients receive anakinra subcutaneously (SC) once daily for 6 months (months 1-6). Based on response, patients continue on treatment in one of three ways.
* Complete response \[CR\], very good partial response \[VGPR\], partial response \[PR\], or minimal response \[MR\]: Patients continue to receive anakinra SC once daily for 6 additional months (months 7-12). Patients who develop disease progression at anytime proceed to treatment with high dose dexamethasone.
* Stable disease: Patients receive low-dose oral dexamethasone once weekly for 6 months (months 7-12) with anakinra SC once daily. Patients who maintain stable disease or responded will continue low-dose oral dexamethasone and anakinra SC once daily for 6 additional months (months 13-18). Patients who develop disease progression at any time proceed to treatment with high dose dexamethasone.
* Progressive disease: Patients receive high-dose oral dexamethasone on days 1-4, 9-12, and 17-20 in months 7, 9, and 11 and on days 1-4 in months 8, 10, and 12 with anakinra SC once daily for 6 additional months (months 7-12).

NOTE: Patients may continue on treatment beyond 12 months at treating physician discretion.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

Conditions

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Multiple Myeloma and Plasma Cell Neoplasm

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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Anakinra with/without Dexamethasone

Anakinra was given alone for 6 months at which time response was assessed.

If participants achieved a minor response or better they continued on Anakinra alone until disease progression.

If participants achieved stable disease, they added low dose Dexamethasone to Anakinra until progression.

If at any time a participant progresses, they were administered high dose Dexamethasone with Anakinra.

Group Type EXPERIMENTAL

Anakinra (IL-1Ra)

Intervention Type BIOLOGICAL

100mg daily subcutaneously administered

Dexamethasone acetate

Intervention Type DRUG

Low dose - 20 mg/week

High dose - 40mg days 1-4, 9-12, 17-20 every 28 days ODD cycles OR 40 mg days 1-4 every 28 days EVEN cycles. (Starting dose was determined by treating physician)

Interventions

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Anakinra (IL-1Ra)

100mg daily subcutaneously administered

Intervention Type BIOLOGICAL

Dexamethasone acetate

Low dose - 20 mg/week

High dose - 40mg days 1-4, 9-12, 17-20 every 28 days ODD cycles OR 40 mg days 1-4 every 28 days EVEN cycles. (Starting dose was determined by treating physician)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No New York Heart Association (NYHA) class III or IV congestive heart failure
* No rheumatoid arthritis or other diseases requiring immunosuppressive therapy
* No asthma, inflammatory bowel disease, or any debilitating physical or psychiatric illness that, in the judgment of the investigator, would interfere with the conduct of the study

PRIOR CONCURRENT THERAPY:

\* More than 30 days since prior treatment with dehydroepiandrosterone (DHEA), clarithromycin, pamidronate, steroids, or any other agent that may affect M-protein

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No