Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	MAYO-MC0282 MC0282, NCT00635154

Objectives

Primary

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

Secondary

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

Entry 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)

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

Patient Characteristics:

• ECOG performance status 0
• Total WBC ≥ 3,500/mm³
• ANC ≥ 1,700/mm³
• 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 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 judgement of the investigator, would interfere with the conduct of the study

Expected Enrollment

Outcomes

Confirmed response (complete response, very good partial response, partial response, or minimal response) after treatment with anakinra alone

Response rate after treatment with dexamethasone and anakinra
Progression-free survival at 6 months
Duration of response

Outline

• Induction therapy: Patients receive anakinra subcutaneously (SC) once daily for 6 months (months 1-6).

  Patients are then assigned to 1 of 3 treatment groups according to their response to induction therapy.




• Group 1 (complete response [CR], very good partial response [VGPR], partial response [PR], minimal response [MR], or stable disease): Patients continue to receive anakinra SC once daily for 6 additional months (months 7-12)*. Patients who develop disease progression proceed to treatment in group 3.



• Group 2 (stable disease): Patients receive low-dose oral dexamethasone once weekly for 6 months (months 7-12). Patients who develop disease progression proceed to treatment in group 3. Patients who maintain stable disease or who achieve CR, VGPR, PR, or MR continue to receive low-dose oral dexamethasone once weekly for 6 additional months (months 13-18) and anakinra SC once daily for 6 additional months (months 13-18)*. Patients who develop disease progression proceed to treatment in group 3.



• Group 3 (progressive disease): Patients continue to receive anakinra SC once daily for 6 additional months (months 7-12)*. Patients also receive high-dose oral dexamethasone once daily 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.

 [Note: *Patients may continue to receive anakinra at the physician's discretion.]

After completion of study treatment, patients are followed periodically.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

John Lust, MD, PhD, Principal investigator		Ph: 507-284-1961 Email: lust.john@mayo.edu

Registry Information
Official Title		A Phase II Study of Anakinra (IL-1 Receptor Antagonist) in Patients with Smoldering/Indolent Multiple Myeloma
Trial Start Date		2002-11-19
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00635154
Date Submitted to PDQ		2008-01-07
Information Last Verified		2008-03-11
NCI Grant/Contract Number		CA15083

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