NCT01383928 is a Phase 1, PHASE2 clinical trial of Ixazomib in Multiple Myeloma, sponsored by Millennium Pharmaceuticals, Inc..

Who is sponsoring NCT01383928?

NCT01383928 is sponsored by Millennium Pharmaceuticals, Inc..

What drugs are being tested in NCT01383928?

Interventions in NCT01383928: Ixazomib, Lenalidomide, Dexamethasone.

What condition does NCT01383928 study?

NCT01383928 studies Multiple Myeloma.

Is NCT01383928 still recruiting?

NCT01383928 is currently completed. Last updated 21 March 2019.

Are results published for NCT01383928?

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

Last reviewed 2019-03-21 · How we verify

NCT01383928

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

Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma

Completed Phase 1, PHASE2 Results posted Last updated 21 March 2019

What this trial tests

Phase 1, PHASE2 trial testing Ixazomib in Multiple Myeloma in 64 participants. Completed in 27 November 2017.

Timeline

31 October 2011

Primary endpoint
13 October 2014

27 November 2017

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	31 October 2011
Primary completion	13 October 2014
Estimated completion	27 November 2017
Sites	20 locations across United States

Drugs / interventions tested

Ixazomib (IXAZOMIB) — full drug profile →
Lenalidomide — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase 1: Maximum Tolerated Dose (MTD) Primary · Cycle 1 (21 days)

MTD was highest dose of ixazomib given with combination drugs, at which \<=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cell per cubic millimeter \[cells/mm\^3\]) for \>7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for \>7 days; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count \<10,000/mm\^3; Grade 2 peripheral neuropathy with pain or \>=Grade 3 peripheral neur

Group	Value	95% CI
Phase 1: All Participants	3.7

Phase 1: Recommended Phase 2 Dose (RP2D) Primary · Cycle 1 (21 days)

The RP2D of ixazomib was determined after the evaluation of the available data from the phase 1 portion of the trial which included, but was not limited to analyses of efficacy results, toxicity characterization, all grades peripheral neuropathy, and treatment discontinuation. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).

Group	Value	95% CI
Phase 1: All Participants	3

Phase 1: Percentage of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) Primary · Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospital

Adverse Event

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	100
Phase 1: Ixazomib 3.7 mg	100

Serious Adverse Event

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	71
Phase 1: Ixazomib 3.7 mg	29

Phase 1: Number of Participants With Markedly Abnormal Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs) Primary · Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)

Laboratory tests included chemistry, hematology and urinalysis. Abnormal laboratory value was assessed as an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Alanine aminotransferase increased

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	0
Phase 1: Ixazomib 3.7 mg	3

Aspartate aminotransferase increased

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	0
Phase 1: Ixazomib 3.7 mg	2

Blood creatinine increased

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	2
Phase 1: Ixazomib 3.7 mg	0

Shift to the left

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	0
Phase 1: Ixazomib 3.7 mg	1

Platelet count decreased

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	1
Phase 1: Ixazomib 3.7 mg	0

Blood bicarbonate decreased

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	1
Phase 1: Ixazomib 3.7 mg	0

Anaemia

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	1
Phase 1: Ixazomib 3.7 mg	0

Neutropenia

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	1
Phase 1: Ixazomib 3.7 mg	0

Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Related to Neurotoxicity Primary · Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)

TEAE related to neurotoxicity grading based on common terminology criteria for adverse events (CTACE) version 4.03 are reported. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening consequences; urgent intervention indicated; Grade 5= death. Only TEAEs related to neurotoxicity with values are reported.

Neuropathy Peripheral (Grade 1)

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	0
Phase 1: Ixazomib 3.7 mg	1

Neuropathy Peripheral (Grade 2)

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	2
Phase 1: Ixazomib 3.7 mg	1

Neuropathy Peripheral (Grade 3)

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	0
Phase 1: Ixazomib 3.7 mg	1

Peripheral Sensory Neuropathy (Grade 1)

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	2
Phase 1: Ixazomib 3.7 mg	1

Peripheral Sensory Neuropathy (Grade 2)

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	0
Phase 1: Ixazomib 3.7 mg	1

Peripheral Sensory Neuropathy (Grade 3)

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	1
Phase 1: Ixazomib 3.7 mg	0

Peripheral Motor Neuropathy (Grade 1)

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	1
Phase 1: Ixazomib 3.7 mg	0

Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Primary · Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)

Vital signs included body temperature, blood pressure and heart rate.

Pyrexia

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	1
Phase 1: Ixazomib 3.7 mg	3

Bradycardia

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	1
Phase 1: Ixazomib 3.7 mg	0

Orthostatic hypotension

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	0
Phase 1: Ixazomib 3.7 mg	1

Hypotension

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	1
Phase 1: Ixazomib 3.7 mg	1

Phase 2: Percentage of Participants With Complete Response (CR) + Very Good Partial Response (VGPR) Primary · Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)

CR as per International Myeloma Working Group (IMWG) uniform criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and \<5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours. VGPR was applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein greater than or equal to (

Group	Value	95% CI
Phase 2: Ixazomib 3 mg	65	50.4 – 78.3

Phase 2: Percentage of Participants With Grade 3 or Higher Adverse Events Primary · Baseline up to 30 days after the last dose of study drug (approximately 1905 days)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. As per Common Terminology Criteria for Adverse Events v4.0 (CTCAE), Grade 3 = AE with severe or medically significant but not immediately life-threa

Group	Value	95% CI
Phase 2: Ixazomib 3 mg	74

Phase 2: Percentage of Participants Experiencing Serious Adverse Events Primary · Baseline up to 30 days after the last dose of study drug (approximately 1905 days)

A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.

Group	Value	95% CI
Phase 2: Ixazomib 3 mg	46

Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Study Drug Discontinuation Primary · Baseline up to 30 days after the last dose of study drug (approximately 1905 days)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

Group	Value	95% CI
Phase 2: Ixazomib 3 mg	14

Phase 1: Cmax: Maximum Plasma Concentration for Ixazomib Secondary · Cycle 1, Days 1 and 11

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.

Day 1

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	33.515	± 22.9634
Phase 1: Ixazomib 3.7 mg	46.946	± 26.6436

Day 11

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	58.674	± 19.9559
Phase 1: Ixazomib 3.7 mg	51.832	± 23.5112

Phase 1: AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib Secondary · Cycle 1, Days 1 and 11

AUC(0-72) is a measure of the area under the plasma concentration time-curve from time zero to 72 hours post-dose for ixazomib.

Day 1

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	315.450	± 75.0886
Phase 1: Ixazomib 3.7 mg	284.576	± 47.8233

Day 11

Group	Value	95% CI
Phase 1: Ixazomib 3 mg	1105.44	± 457.5939
Phase 1: Ixazomib 3.7 mg	1023.52	± 284.3709

Adverse events — posted to ClinicalTrials.gov

Time frame: From first study drug administration up to 30 days after the last dose (Up to approximately 2067 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1: Ixazomib 3 mg

Serious: 5/7 (71%)

Deaths: 0/7

Phase 1: Ixazomib 3.7 mg

Serious: 2/7 (29%)

Deaths: 0/7

Phase 2: Ixazomib 3.0 mg

Serious: 23/50 (46%)

Deaths: 1/50

Serious adverse events (50 terms)

Reaction	System	Phase 1: Ixazomib 3 mg	Phase 1: Ixazomib 3.7 mg	Phase 2: Ixazomib 3.0 mg
Pneumonia	Infections and infestations	—	—	—
Lung infection	Infections and infestations	—	—	—
Cellulitis	Infections and infestations	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Skin infection	Infections and infestations	—	—	—
Subcutaneous abscess	Infections and infestations	—	—	—
Influenza	Infections and infestations	—	—	—
Scrotal infection	Infections and infestations	—	—	—
Infective myositis	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Guillain-Barre syndrome	Nervous system disorders	—	—	—
Syncope	Nervous system disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Amnesia	Nervous system disorders	—	—	—
Cognitive disorder	Nervous system disorders	—	—	—
Neuropathy peripheral	Nervous system disorders	—	—	—
Atrial flutter	Cardiac disorders	—	—	—
Cardiac failure	Cardiac disorders	—	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Intestinal perforation	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—

Other adverse events (171 terms — click to expand)

Reaction	System	Phase 1: Ixazomib 3 mg	Phase 1: Ixazomib 3.7 mg	Phase 2: Ixazomib 3.0 mg
Fatigue	General disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Oedema peripheral	General disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Dysgeusia	Nervous system disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Neuropathy peripheral	Nervous system disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Vision blurred	Eye disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Anxiety	Psychiatric disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Asthenia	General disorders	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—
Peripheral swelling	General disorders	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—
Sinusitis	Infections and infestations	—	—	—
Pyrexia	General disorders	—	—	—
Tremor	Nervous system disorders	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: Pneumonia, Lung infection, Cellulitis, Atrial fibrillation, Skin infection, Subcutaneous abscess, Influenza, Scrotal infection.

Data from ClinicalTrials.gov NCT01383928 adverse events section.

Sponsor's own description

The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).

Publications & conference data

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

Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients.
Richardson PG, Baz R, Wang M, Jakubowiak AJ, et al · · 2014 · cited 162× · PMID 24920586 · DOI 10.1182/blood-2014-01-548826
Spotlight on ixazomib: potential in the treatment of multiple myeloma.
Muz B, Ghazarian RN, Ou M, Luderer MJ, et al · · 2016 · cited 87× · PMID 26811670 · DOI 10.2147/dddt.s93602
Population Pharmacokinetic Analysis of Ixazomib, an Oral Proteasome Inhibitor, Including Data from the Phase III TOURMALINE-MM1 Study to Inform Labelling.
Gupta N, Diderichsen PM, Hanley MJ, Berg D, et al · · 2017 · cited 31× · PMID 28290121 · DOI 10.1007/s40262-017-0526-4
Lenalidomide for the treatment of relapsed and refractory multiple myeloma.
van de Donk NW, Görgün G, Groen RW, Jakubikova J, et al · · 2012 · cited 30× · PMID 22956884 · DOI 10.2147/cmar.s27087
The role of high-dose melphalan with autologous stem-cell transplant in multiple myeloma: is it time for a paradigm shift?
Kazandjian D, Mo CC, Landgren O, Richardson PG. · · 2020 · cited 25× · PMID 32501533 · DOI 10.1111/bjh.16764
Twice-weekly ixazomib in combination with lenalidomide-dexamethasone in patients with newly diagnosed multiple myeloma.
Richardson PG, Hofmeister CC, Rosenbaum CA, Htut M, et al · · 2018 · cited 24× · PMID 29938772 · DOI 10.1111/bjh.15394
Lenalidomide use in multiple myeloma (Review).
Zhang CW, Wang YN, Ge XL. · · 2024 · cited 16× · PMID 38125742 · DOI 10.3892/mco.2023.2705
19th Congress of the European Hematology Association, Milan, Italy, June 12–15, 2014
· 2014

Verify or expand the search:

Other trials of Ixazomib

Trials testing the same drug.

NCT05722405 — Ixazomib Plus Low-dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma · Phase 4 · recruiting
NCT05183139 — A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone or With Lenalidomide an · Phase 4 · withdrawn
NCT04998786 — A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myel · Phase 2 · active not recruiting
NCT04837131 — A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients · Phase 2 · terminated
NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob · Phase 1 · withdrawn

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 Millennium Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob · Phase 1 · withdrawn
NCT04056468 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepati · Phase 1 · completed
NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab · Phase 1 · completed
NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys · Phase 1 · completed
NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia · Phase 1 · completed

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 NCT01383928 (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 Millennium Pharmaceuticals, Inc.
Last refreshed: 21 March 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/NCT01383928.

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