Last reviewed · How we verify
NCT00002787
Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLH/GM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation
Phase 1 trial testing autologous immunoglobulin idiotype-KLH conjugate vaccine in Refractory Multiple Myeloma in 22 participants. Completed.
1 December 2002
Quick facts
| Lead sponsor | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 1 March 1996 |
| Primary completion | 1 December 2002 |
| Sites | 1 location across United States |
Drugs / interventions tested
- autologous immunoglobulin idiotype-KLH conjugate vaccine — full drug profile →
- sargramostim (SARGRAMOSTIM) — full drug profile →
- aldesleukin (ALDESLEUKIN) — full drug profile →
- laboratory biomarker analysis — full drug profile →
Conditions studied
- Refractory Multiple Myeloma — all drugs for Refractory Multiple Myeloma →
- Stage I Multiple Myeloma — all drugs for Stage I Multiple Myeloma →
- Stage II Multiple Myeloma — all drugs for Stage II Multiple Myeloma →
- Stage III Multiple Myeloma — all drugs for Stage III Multiple Myeloma →
Sponsor
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Who can join
Eligibility, any sex, with Refractory Multiple Myeloma or Stage I Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria
Time frame: Up to 2 years
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort. -
Immune response
Time frame: Up to 2 years
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
Sponsor's own description
The purpose of this trial is to test the safety and immune response to four immunizations with this vaccine made from a protein produced by the patient's tumor. There is no guarantee or promise that this procedure will be successful
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00002787
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of autologous immunoglobulin idiotype-KLH conjugate vaccine
Trials testing the same drug.
- NCT00621036 — Vaccine Therapy and GM-CSF in Treating Patients With CNS Lymphoma · Phase 2 · withdrawn
Other recruiting trials for Refractory Multiple Myeloma
Currently open trials in the same condition.
- NCT07181941 — Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refrac · Phase 1, PHASE2 · recruiting
- NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
- NCT07093554 — Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patie · Phase 1 · recruiting
- NCT07045727 — Prehabilitation With Aerobic and Resistance Exercise for Improving Physical Fitness and Quality of Life Outcomes in Olde · NA · recruiting
- NCT06348108 — Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00002787 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Last refreshed: 2 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00002787.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing