NCT00511238 is a Phase 2 clinical trial of carfilzomib in Multiple Myeloma, sponsored by Amgen.

Who is sponsoring NCT00511238?

NCT00511238 is sponsored by Amgen.

What drugs are being tested in NCT00511238?

Interventions in NCT00511238: carfilzomib, carfilzomib.

What condition does NCT00511238 study?

NCT00511238 studies Multiple Myeloma.

Is NCT00511238 still recruiting?

NCT00511238 is currently completed. Last updated 2 August 2017.

Are results published for NCT00511238?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-08-02 · How we verify

NCT00511238

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open-label, Single-arm, Phase 2 Study of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma

Completed Phase 2 Results posted Last updated 2 August 2017

What this trial tests

Phase 2 trial testing carfilzomib in Multiple Myeloma in 312 participants. Completed in 1 October 2012.

Timeline

1 August 2007

Primary endpoint
1 November 2010

1 October 2012

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	312
Start date	1 August 2007
Primary completion	1 November 2010
Estimated completion	1 October 2012
Sites	34 locations across United States, Canada

Drugs / interventions tested

carfilzomib (carfilzomib) — full drug profile →
carfilzomib (carfilzomib) — full drug profile →

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Amgen — full company profile →

Who can join

18 and older, any sex, with 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.

Best Overall Response Rate (ORR)
Time frame: A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.
For both A0 and A1, to evaluate the best overall response rate (stringent complete response \[sCR\]+ complete response \[CR\]+ very good partial response \[VGPR\]+ partial response \[PR\]) in patients with multiple myeloma who had previously received bortezomib and either thalidomide or lenalidomide, had relapsed after two or more therapies, and were refractory to the most recently received therap

Sponsor's own description

To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects with relapsed and refractory multiple myeloma. Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Natural products: a continuing source of novel drug leads.
Cragg GM, Newman DJ. · · 2013 · cited 1483× · PMID 23428572 · DOI 10.1016/j.bbagen.2013.02.008
A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma.
Siegel DS, Martin T, Wang M, Vij R, et al · · 2012 · cited 492× · PMID 22833546 · DOI 10.1182/blood-2012-05-425934
Integrated safety profile of single-agent carfilzomib: experience from 526 patients enrolled in 4 phase II clinical studies.
Siegel D, Martin T, Nooka A, Harvey RD, et al · · 2013 · cited 258× · PMID 23935022 · DOI 10.3324/haematol.2013.089334
An open-label, single-arm, phase 2 study of single-agent carfilzomib in patients with relapsed and/or refractory multiple myeloma who have been previously treated with bortezomib.
Vij R, Siegel DS, Jagannath S, Jakubowiak AJ, et al · · 2012 · cited 139× · PMID 22845873 · DOI 10.1111/j.1365-2141.2012.09232.x
CHAMPION-1: a phase 1/2 study of once-weekly carfilzomib and dexamethasone for relapsed or refractory multiple myeloma.
Berenson JR, Cartmell A, Bessudo A, Lyons RM, et al · · 2016 · cited 82× · PMID 27207788 · DOI 10.1182/blood-2015-11-683854
Phase Ib dose-escalation study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma.
Niesvizky R, Martin TG, Bensinger WI, Alsina M, et al · · 2013 · cited 67× · PMID 23447001 · DOI 10.1158/1078-0432.ccr-12-3352
Emerging agents and regimens for multiple myeloma.
Yang Y, Li Y, Gu H, Dong M, et al · · 2020 · cited 57× · PMID 33168044 · DOI 10.1186/s13045-020-00980-5
Treatment outcomes in patients with relapsed and refractory multiple myeloma and high-risk cytogenetics receiving single-agent carfilzomib in the PX-171-003-A1 study.
Jakubowiak AJ, Siegel DS, Martin T, Wang M, et al · · 2013 · cited 57× · PMID 23670297 · DOI 10.1038/leu.2013.152

Verify or expand the search:

Other trials of carfilzomib

Trials testing the same drug.

NCT05017545 — Carfilzomib and Belatacept for Desensitization · Phase 1, PHASE2 · active not recruiting
NCT03275285 — Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Rel · Phase 3 · completed
NCT02293109 — Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma · Phase 1 · completed
NCT01738594 — Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma · Phase 1 · terminated
NCT01246063 — Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refr · Phase 1, PHASE2 · completed

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00511238 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 2 August 2017

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/NCT00511238.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing