Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00635154

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Biological: anakinra Drug: dexamethasone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Anakinra (IL-1 Receptor Antagonist) in Patients With Smoldering/Indolent Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Anakinra Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Confirmed response (complete response, very good partial response, partial response, or minimal response) after treatment with anakinra alone [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate after treatment with dexamethasone and anakinra [ Designated as safety issue: No ]
Progression-free survival at 6 months [ Designated as safety issue: No ]
Duration of response [ Designated as safety issue: No ]

Estimated Enrollment:	55
Study Start Date:	November 2002
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

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 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635154

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator:

John A. Lust, MD, PhD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000583300, MAYO-MC0282
Study First Received:	March 12, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00635154 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Interleukin 1 Receptor Antagonist Protein
Dexamethasone acetate

Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Vascular Diseases
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 25, 2009