NCT00530816 is a Phase 2 clinical trial of carfilzomib in Multiple Myeloma, sponsored by Amgen.

Who is sponsoring NCT00530816?

NCT00530816 is sponsored by Amgen.

What drugs are being tested in NCT00530816?

Interventions in NCT00530816: carfilzomib.

What condition does NCT00530816 study?

NCT00530816 studies Multiple Myeloma.

Is NCT00530816 still recruiting?

NCT00530816 is currently completed. Last updated 28 April 2017.

Are results published for NCT00530816?

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

Last reviewed 2017-04-28 · How we verify

NCT00530816

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 or Refractory Multiple Myeloma

Completed Phase 2 Results posted Last updated 28 April 2017

What this trial tests

Phase 2 trial testing carfilzomib in Multiple Myeloma in 164 participants. Completed in 1 July 2013.

Timeline

1 September 2007

Primary endpoint
1 January 2013

1 July 2013

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	164
Start date	1 September 2007
Primary completion	1 January 2013
Estimated completion	1 July 2013
Sites	30 locations across United States, Canada

Drugs / interventions tested

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) in the Response Evaluable Subset Population
Time frame: Disease response was assessed on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12, and at End of Study, 30 days after last dose. Median duration of treatment was 100 days for Part 1 and 170 days for Part 2 participants.
ORR is defined as the percentage of patients who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) determined by Independent Review Committee (IRC). Responses were assessed according to International Uniform Response Criteria for Multiple Myeloma, documented by 2 consecutive assessments made at any time

Sponsor's own description

To evaluate the best overall response rate, safety and tolerability of carfilzomib in patients with relapsed or refractory multiple myeloma.

Publications & conference data

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

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 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma.
Vij R, Wang M, Kaufman JL, Lonial S, et al · · 2012 · cited 192× · PMID 22555973 · DOI 10.1182/blood-2012-03-414359
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
Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials.
Chari A, Stewart AK, Russell SD, Moreau P, et al · · 2018 · cited 54× · PMID 29991494 · DOI 10.1182/bloodadvances.2017015545
Incidence and management of adverse events in patients with relapsed and/or refractory multiple myeloma receiving single-agent carfilzomib.
Harvey RD. · · 2014 · cited 45× · PMID 24855395 · DOI 10.2147/cpaa.s62512
Clinical activity of carfilzomib correlates with inhibition of multiple proteasome subunits: application of a novel pharmacodynamic assay.
Lee SJ, Levitsky K, Parlati F, Bennett MK, et al · · 2016 · cited 26× · PMID 27071340 · DOI 10.1111/bjh.14014
From clinical trials to clinical practice: single-agent carfilzomib adverse events and their management in patients with relapsed and/or refractory multiple myeloma.
Siegel DS. · · 2013 · cited 24× · PMID 24319571 · DOI 10.1177/2040620713511176
The future of proteasome inhibitors in relapsed/refractory multiple myeloma.
Orlowski RZ. · · 2011 · cited 1× · PMID 25188482

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 NCT00530816 (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: 28 April 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/NCT00530816.

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