Clinical trial NCT00635154
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma
Sponsor: Mayo Clinic
Start date: 2002-12-01; Completion date: 2010-11-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: 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.
Interventions: intervention 1: Anakinra (IL-1Ra) intervention 2: Dexamethasone acetate
Intervention descriptions: intervention 1: 100mg daily subcutaneously administered intervention 2: 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)

Protocol documents: