Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
55 patients were recruited from November 2002 through December 2007 at Mayo Clinic. One patient had progressive disease prior to starting treatment. This patient was excluded from all analysis.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients received induction therapy of Anakinra alone for 6 months. Based on response, dexamethasone could be added or increased in subsequent cycles. See the Outline section for more detail. Unless otherwise stated, results are reported for all patients (regardless of dexamethasone administration).

Reporting Groups

	Description
Anakinra With/Without Dexamethasone	No text entered.

Participant Flow:   Overall Study

	Anakinra With/Without Dexamethasone
STARTED	54
COMPLETED	21
NOT COMPLETED	33
Alternative Treatment	8
Other	4
Still on treatment	21

Reporting Groups

	Description
Anakinra With/Without Dexamethasone	No text entered.

Baseline Measures

	Anakinra With/Without Dexamethasone
Number of Participants   [units: participants]	54
Age   [units: years] Median ( Full Range )	60.0     ( 38 to 79 )
Gender   [units: participants]
Female	25
Male	29
Region of Enrollment   [units: participants]
United States	54
Diagnosis   [units: participants]
Smoldering Multiple Myeloma (SMM)	44
Indolent Multiple Myeloma (IMM)	10
Prior treatment for M-protein   [units: participants]
Yes	10
No	44

1.  Primary:

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   [ Time Frame: 6 months ]

2.  Secondary:

Number of Patients With Response to Treatment With Dexamethasone and Anakinra   [ Time Frame: During Active treatment (up to 5 years) ]

3.  Secondary:

Number of Patients Who Are Progression-free and Alive at 6 Months   [ Time Frame: at 6 months ]

4.  Secondary:

Number of Patients With Severe Non-hematological Adverse Events in Patients Receiving Anakinra Alone or in Combination With Dexamethasone.   [ Time Frame: Duration of treatment (up to 5 years) ]

5.  Secondary:

Progression Free Survival (PFS) in Patients Treated With Anakinra Alone or in Combination With Dexamethasone   [ Time Frame: Time from registration to progression or death (up to 5 years) ]

6.  Secondary:

Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone   [ Time Frame: every cycle during treatment (up to 5 years) ]

7.  Secondary:

Duration of Response   [ Time Frame: From first documentation of response to progression or last follow-up (up to 5 years) ]