A Phase II Study of Anakinra (IL-1 Receptor Antagonist) in Patients With Smoldering/Indolent Multiple Myeloma
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone
Response Definitions: Complete Response(CR):disappearance of M-Protein from serum & urine and immunofixation, <5% bone marrow(BM) plasma cells & disappearance of soft tissue plasmacytomas(STP); Very Good Partial Response(VGPR):>=90% decrease in serum M-Protein, Urine M-protein <100 mg/24 hours, <=5% BM plasma cells, disappearance of STP; Partial response(PR):>=50% reduction in serum M-protein, >=90% decrease in Urine M-protein or <200 mg/24 hours & >=50% decrease in STP; Minor response(MR):25-49% decrease in serum M-protein, 50-89% decrease in urine M-protein & 25-49% decrease in STP
6 months
No
John A. Lust, MD, PhD
Principal Investigator
Mayo Clinic
United States: Food and Drug Administration
CDR0000583300
NCT00635154
December 2002
November 2010
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |