NCT00635154

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

A Phase II Study of Anakinra (IL-1 Receptor Antagonist) in Patients With Smoldering/Indolent Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Anakinra (IL-1Ra)	100mg daily subcutaneously administered
DRUG	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)

Timeline

• Start date: 2002-12-01
• Primary completion: 2009-12-01
• Completion: 2010-11-01
• First posted: 2008-03-13
• Last updated: 2018-06-07
• Results posted: 2010-12-09

Locations

1 site across 1 country: United States