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A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ixazomib

Lenalidomide

Dexamethasone

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Drug therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Each patient must meet all of the following eligibility criteria to be enrolled in the study:

Male or female patients 18 years or older
Previously untreated multiple myeloma diagnosed according to standard criteria requiring systemic treatment
Patients must have measurable disease
Nonsecretory multiple myeloma based upon standard M-component criteria (i.e., measurable serum/urine M-component) is not allowed unless the baseline serum free light chain level (Freelite™) is evaluated Patients must meet clinical laboratory criteria as specified in study protocol
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Female and male patients MUST adhere to the guidelines of the lenalidomide pregnancy prevention program
Must be able to take concurrent aspirin 325 mg daily
Voluntary written consent

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

Peripheral neuropathy that is greater or equal to Grade 2
Female patients who are lactating or pregnant
Major surgery or radiotherapy within 14 days before the first dose of study drug
Serious infection requiring systemic antibiotic therapy within 14 days before the first dose of study drug
Diarrhea greater than Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events
Central nervous system involvement.
Evidence of current uncontrolled cardiovascular conditions within the past 6 months
Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
Known gastrointestinal condition that could interfere with swallowing or the oral absorption or tolerance of ixazomib
No other prior malignancy within 2 years except nonmelanoma skin cancer or carcinoma in situ of any type if they have undergone complete resection

Sites / Locations

Mayo Clinic Arizona
Cedars Sinai Medical Center
Rocky Mountain Cancer Center Rose
Cancer Center of Central Connecticut
Mayo Clinic Jacksonville
Mt Sinai Medical Center
Emory University
Harry and Jeannette Weinberg Cancer Center at Franklin Square Hospital
Dana Farber Cancer Institute
Karmanos Cancer Institute
Mayo Clinic
Washington University
New York Presbyterian Hospital - Weill-Cornell
Sarah Cannon Cancer Center
W VA University Mary Babb Randolph Cancer Center
The Medical College of Wisconsin, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone

Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone

Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone

Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone

Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone

Arm Description

In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

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 serious adverse event (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.

Phase 2: Objective Response Rate (ORR) Following Treatment With the Combination Of Oral Ixazomib, Lenalidomide And Low-Dose Dexamethasone

ORR was defined as the percentage of participants with Complete (CR) + Very Good Partial Response (VGPR) assessed by the investigatory using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR=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.

Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone

RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.

Phase 1: Maximum Tolerated Dose (MTD) of Ixazomib Administered Weekly in Combination With Lenalidomide and Low-Dose Dexamethasone

MTD of ixazomib will be determined by assessing adverse events and serious adverse events, clinical laboratory values, neurotoxicity grading, and vital sign measurements.

Phase 2: Percentage of Participants With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation

Secondary Outcome Measures

Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib

Cmax: Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of ixazomib obtained directly from the plasma concentration-time curve.

Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib

Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.

Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib

AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.

Phase 1: Rac: Accumulation Ratio of Ixazomib

The accumulation ratio (Rac) was estimated as the ratio of AUC(0-168) on Day 15 to the AUC(0-168) on Day 1. AUC(0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose for ixazomib.

Phase 1: Emax: Maximum Observed Inhibition of Whole Blood 20S Proteasome

Emax is the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory's performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.

Phase 1: TEmax: Time to the Maximum Observed Inhibition of Whole Blood 20S Proteasome

TEmax is the time to the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory's performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.

Phase 2: Time to Progression (TTP)

TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD).

Phase 2: Overall Survival (OS)

OS was measured as the time in months from the first dose of study treatment to the date of death + 1 day.

Phase 2: Overall Response Rate (ORR)

ORR was defined as the percentage of participants with CR, VGPR and Partial Response (PR) assessed by the investigator using IMWG criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. PR=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 90% or to < 200 mg per 24 hours. VGPR= 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.

Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)

Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR 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.

Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)

Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. sCR= CR + Normal free light chain (FLC) ratio and Absence of clonal cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to < 200 mg per 24 hours. VGPR= 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. nCR=Positive immunofixation analysis of serum or urine as the only evidence of disease. Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. MR=25% to 49% reduction in serum paraprotein and 50% to 89% reduction in urine light chain excretion for 6 weeks.

Phase 2: Time to Best Response

Time to Best Response was measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.

Phase 2: Duration of Response (DOR)

DOR was measured as the time in months from the date of first documentation of a confirmed response (CR + PR+ VGPR) to the date of the first documented disease progression (PD). Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. VGPR=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.

Phase 2: Progression Free Survival (PFS)

PFS was measured as the time in months from the first dose of study treatment to the date of the first documented PD or death.

Phase 2: 1 Year Survival Rate

1-year survival rate is defined as the percentage of participants still alive at year after the first dose of stud drug.

Full Information

NCT ID

NCT01217957

First Posted

September 24, 2010

Last Updated

March 12, 2018

Sponsor

Millennium Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01217957

Brief Title

A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Official Title

An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of Ixazomib (MLN9708), a Second-Generation Proteasome Inhibitor, Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

November 22, 2010 (Actual)

Primary Completion Date

March 8, 2013 (Actual)

Study Completion Date

February 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in combination with lenalidomide and low-dose dexamethasone in participants with newly diagnosed multiple myeloma (NDMM). The purpose of Phase 2 of this study was to determine the overall response rate (ORR) and further evaluate the tolerability and toxicity of the combination of oral ixazomib, lenalidomide, and low-dose dexamethasone in patients with NDMM.

Detailed Description

The drug being tested in this study is called ixazomib. Ixazomib was being tested to treat people who had newly diagnosed multiple myeloma who had not previously received systemic treatment. This study was conducted in two Phases. Phase 1 looked at side effects and lab results in people who took ixazomib to determine the MTD and RP2D. Phase 2 looked at overall response rates and side effects in people who took ixazomib. The study enrolled 15 patients in Phase 1 and 50 patients in Phase 2. Participants in Phase 1 were assigned to cohorts and received ixazomib 1.68, 2.23, 2.97, or 3.95 mg/m^2 in addition to dexamethasone 40 mg and lenalidomide 25 mg. Participants in Phase 2 received ixazomib 4.0 mg fixed dose in addition to dexamethasone 40 mg and lenalidomide 25 mg. In both Phases study treatment was administered in 28-day Cycles as follows: ixazomib Days 1, 8 and 15, dexamethasone Days 1, 8, 15 and 22, and lenalidomide 25 mg Days 1 through 21. This multi-center trial was conducted in the United States. The overall time to participate in this study was 12, 28-day cycles with the option to continue into a maintenance portion in the absence of disease progression or unacceptable toxicity. Participants made multiple visits to the clinic and a final visit 30 days after last dose of study drug for a follow-up assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Drug therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone

Arm Type

Experimental

Arm Description

Arm Title

Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone

Arm Type

Experimental

Arm Description

Arm Title

Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone

Arm Type

Experimental

Arm Description

Arm Title

Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone

Arm Type

Experimental

Arm Description

Arm Title

Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ixazomib

Other Intervention Name(s)

MLN9708, NINLARO®

Intervention Description

Ixazomib capsules

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Intervention Description

Lenalidomide capsules

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone tablets

Primary Outcome Measure Information:

Title

Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

Description

Time Frame

Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)

Title

Phase 2: Objective Response Rate (ORR) Following Treatment With the Combination Of Oral Ixazomib, Lenalidomide And Low-Dose Dexamethasone

Description

Time Frame

Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)

Title

Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone

Description

RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.

Time Frame

Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)

Title

Phase 1: Maximum Tolerated Dose (MTD) of Ixazomib Administered Weekly in Combination With Lenalidomide and Low-Dose Dexamethasone

Description

MTD of ixazomib will be determined by assessing adverse events and serious adverse events, clinical laboratory values, neurotoxicity grading, and vital sign measurements.

Time Frame

Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)

Title

Phase 2: Percentage of Participants With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation

Description

Time Frame

Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)

Secondary Outcome Measure Information:

Title

Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib

Description

Cmax: Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of ixazomib obtained directly from the plasma concentration-time curve.

Time Frame

Cycle 1, Days 1 and 15

Title

Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib

Description

Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.

Time Frame

Cycle 1, Days 1 and 15

Title

Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib

Description

AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.

Time Frame

Cycle 1, Days 1 and 15

Title

Phase 1: Rac: Accumulation Ratio of Ixazomib

Description

Time Frame

Cycle 1, Day 15

Title

Phase 1: Emax: Maximum Observed Inhibition of Whole Blood 20S Proteasome

Description

Time Frame

Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose

Title

Phase 1: TEmax: Time to the Maximum Observed Inhibition of Whole Blood 20S Proteasome

Description

Time Frame

Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose

Title

Phase 2: Time to Progression (TTP)

Description

TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD).

Time Frame

From the first dose of study treatment to the date of first documented progressive disease (Up to 787 days)

Title

Phase 2: Overall Survival (OS)

Description

OS was measured as the time in months from the first dose of study treatment to the date of death + 1 day.

Time Frame

From the first dose of study treatment to the date of death (up to 787 days)

Title

Phase 2: Overall Response Rate (ORR)

Description

Time Frame

Up to 787 days

Title

Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)

Description

Time Frame

After Cycles 3, 6 and 9 (Up to 787 days)

Title

Description

Time Frame

Cycles 3, 6, 9 and 12 (Up to 787 days)

Title

Phase 2: Time to Best Response

Description

Time Frame

Up to 787 days

Title

Phase 2: Duration of Response (DOR)

Description

Time Frame

Up to 787 days

Title

Phase 2: Progression Free Survival (PFS)

Description

PFS was measured as the time in months from the first dose of study treatment to the date of the first documented PD or death.

Time Frame

Up to 787 days

Title

Phase 2: 1 Year Survival Rate

Description

1-year survival rate is defined as the percentage of participants still alive at year after the first dose of stud drug.

Time Frame

1 year after first dose of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Each patient must meet all of the following eligibility criteria to be enrolled in the study: Male or female patients 18 years or older Previously untreated multiple myeloma diagnosed according to standard criteria requiring systemic treatment Patients must have measurable disease Nonsecretory multiple myeloma based upon standard M-component criteria (i.e., measurable serum/urine M-component) is not allowed unless the baseline serum free light chain level (Freelite™) is evaluated Patients must meet clinical laboratory criteria as specified in study protocol Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Female and male patients MUST adhere to the guidelines of the lenalidomide pregnancy prevention program Must be able to take concurrent aspirin 325 mg daily Voluntary written consent Exclusion Criteria Patients meeting any of the following exclusion criteria are not to be enrolled in the study: Peripheral neuropathy that is greater or equal to Grade 2 Female patients who are lactating or pregnant Major surgery or radiotherapy within 14 days before the first dose of study drug Serious infection requiring systemic antibiotic therapy within 14 days before the first dose of study drug Diarrhea greater than Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events Central nervous system involvement. Evidence of current uncontrolled cardiovascular conditions within the past 6 months Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol Known gastrointestinal condition that could interfere with swallowing or the oral absorption or tolerance of ixazomib No other prior malignancy within 2 years except nonmelanoma skin cancer or carcinoma in situ of any type if they have undergone complete resection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Millennium Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Mayo Clinic Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

Cedars Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Rocky Mountain Cancer Center Rose

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Cancer Center of Central Connecticut

City

Southington

State/Province

Connecticut

ZIP/Postal Code

06489

Country

United States

Facility Name

Mayo Clinic Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Mt Sinai Medical Center

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Harry and Jeannette Weinberg Cancer Center at Franklin Square Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21215

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

New York Presbyterian Hospital - Weill-Cornell

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Sarah Cannon Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

W VA University Mary Babb Randolph Cancer Center

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

The Medical College of Wisconsin, Inc.

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28803351

Citation

Gupta N, Yang H, Hanley MJ, Zhang S, Liu R, Kumar S, Richardson PG, Skacel T, Venkatakrishnan K. Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses. Target Oncol. 2017 Oct;12(5):643-654. doi: 10.1007/s11523-017-0524-3.

Results Reference

derived

PubMed Identifier

25456369

Citation

Kumar SK, Berdeja JG, Niesvizky R, Lonial S, Laubach JP, Hamadani M, Stewart AK, Hari P, Roy V, Vescio R, Kaufman JL, Berg D, Liao E, Di Bacco A, Estevam J, Gupta N, Hui AM, Rajkumar V, Richardson PG. Safety and tolerability of ixazomib, an oral proteasome inhibitor, in combination with lenalidomide and dexamethasone in patients with previously untreated multiple myeloma: an open-label phase 1/2 study. Lancet Oncol. 2014 Dec;15(13):1503-1512. doi: 10.1016/S1470-2045(14)71125-8. Epub 2014 Nov 14. Erratum In: Lancet Oncol. 2019 Jul;20(7):e346.

Results Reference

derived

Learn more about this trial

A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

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