Phase 2
N=54
Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT00635154 ↗Enrolled (actual)
54
Serious AEs
14.8%
Results posted
Dec 2010
Primary outcome: 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 — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anakinra (IL-1Ra) (Biological); Dexamethasone acetate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
1 | — |
| SECONDARY Number of Patients With Response to Treatment With Dexamethasone and Anakinra |
14 | — |
| SECONDARY Number of Patients Who Are Progression-free and Alive at 6 Months |
49 | — |
| SECONDARY Number of Patients With Severe Non-hematological Adverse Events in Patients Receiving Anakinra Alone or in Combination With Dexamethasone. |
7 | — |
| SECONDARY Progression Free Survival (PFS) in Patients Treated With Anakinra Alone or in Combination With Dexamethasone |
37.5 | — |
| SECONDARY Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone |
4 | — |
| SECONDARY Duration of Response |
41.9 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00635154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.