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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- New or preexisting diagnosis of multiple myeloma

- Smoldering or indolent multiple myeloma meeting one of the following criteria:

- Bone marrow plasma cells ≥ 10%

- Serum monoclonal IgG or IgA protein ≥ 3.0 g/dL OR urine monoclonal light chain ≥
1g by 24-hour urine protein electrophoresis

- Measurable disease

- Does not require immediate chemotherapy, in the opinion of the treating physician

- No active myeloma or primary amyloidosis requiring chemotherapy or any agents that
may interact with anakinra (e.g., etanercept, infliximab, or thalidomide)

PATIENT CHARACTERISTICS:

- Eastern Cooperative Oncology Group (ECOG) performance status 0

- Total WBC ≥ 3,500/mm^3

- ANC ≥ 1,700/mm^3

- Creatinine ≤ 1.5 times upper limit of normal

- Able to self-inject medication or have a caregiver who can administer the drug

- Not pregnant or nursing

- Negative pregnancy test

- No acute or chronic infections, open wounds, or any active infection requiring
intravenous antibiotic therapy within the past 12 weeks

- No active malignancy within the past 5 years except basal cell carcinoma of the skin
or carcinoma in situ of cervix

- Patients with a previously resected malignancy that does not require further
treatment are eligible

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

John A. Lust, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000583300

NCT ID:

NCT00635154

Start Date:

December 2002

Completion Date:

November 2010

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Mayo ClinicRochester, Minnesota  55905