Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00635154 · ClinicalTrials.gov registry record · Phase 2
Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00635154: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT00635154 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00635154, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study 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.
Primary Outcome
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; * Mino
Interventions
- BIOLOGICAL Anakinra (IL-1Ra)
- DRUG Dexamethasone acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2002-12 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
What the finished NCT00635154 record still lists
NCT00635154 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Anakinra (IL-1Ra) is the first listed.
NCT00635154 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00635154 about?
NCT00635154 is a clinical study titled "Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma". 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 eff...
What is the current status of trial NCT00635154?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2002-12. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00635154?
The interventions under investigation include: Anakinra (IL-1Ra) (BIOLOGICAL), Dexamethasone acetate (DRUG).
Who is sponsoring clinical trial NCT00635154?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00635154's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01638676 · 55 participants · Phase 1
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
- NCT01906385 · 55 participants · Phase 1
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
- NCT03007030 · 55 participants · Phase 2
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
- NCT03152058 · 55 participants · Phase 2
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia