NCT01903811|CompletedPhase 2ResultsDMC

S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma

A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) With Dexamethasone for Multiple Myeloma Patients With Relapsed or Refractory Disease

SWOG Cancer Research Network ClinicalTrials.gov

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6 other identifiers

S1304NCI-2013-00796PS1304_A07PAMDREVW01SWOG-S1304U10CA180888U10CA032102

Study Type

interventional

Target

143

Locations

1 country

Sites

485

Timeline

RegisteredJul 2013

StartedOct 2013

CompletionMar 2019

Brief Summary

This randomized phase II trial compares how well two different doses of carfilzomib work when given with dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib together with dexamethasone may kill more cancer cells. It is not yet known whether a higher or lower dose of carfilzomib works better when given with dexamethasone.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

143

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2013

Longer than P75 for phase_2

Geographic Reach

1 country

485 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.4 years study duration

First Submitted

Initial submission to the registry

July 16, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed

2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2017

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2019

Completed

6 months until next milestone

Results Posted

Study results publicly available

September 6, 2019

Completed

Last Updated

December 20, 2024

Status Verified

November 1, 2024

Enrollment Period

4.1 years

First QC Date

July 16, 2013

Results QC Date

June 20, 2019

Last Update Submit

November 26, 2024

Conditions

Recurrent Plasma Cell Myeloma Refractory Plasma Cell Myeloma

Keywords

carfilzomibrelapsedrefractorymultiple myeloma

Outcome Measures

Primary Outcomes (1)

Progression-free Survival
Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified long-rank test. Progression is defined using the International Uniform Response Criteria for Multiple Myeloma as new or increase in size of existing bone lesions or soft tissue plasmacytomas; or development of hypercalcemia attributable solely to MM; or ≥ 25% increase from baseline or lowest response level of either serum M protein, urine M protein, difference in involved \& uninvolved serum free light chain level or bone marrow plasma cell percentage.
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 2 years

Secondary Outcomes (4)

Overall Survival
From date of registration to date of death due to any cause, assessed up to 3 years
Best Overall Response - Partial Response (PR), Very Good Partial Response (VGPR), Unconfirmed PR (uPR), Stable Disease (SD) Progression (PROG)
From date of registration to date of best response while on study treatment
Progression-free Survival of Crossover Group
From date of crossover to date of subsequent documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years from randomization
Overall Survival Crossover Group
From date of crossover to date of death due to any cause, assessed up to 3 years from randomization

Other Outcomes (2)

Gene Expression Profiles
Up to 3 years
Incidence of CR by PET, Defined as the Disappearance of All Focal Lesions and the Resolution of EMD
Up to week 45

Study Arms (2)

Arm I (dexamethasone, low-dose carfilzomib)

EXPERIMENTAL

Patients receive dexamethasone IV and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II.

Drug: CarfilzomibDrug: DexamethasoneOther: Laboratory Biomarker Analysis

Arm II (dexamethasone, high-dose carfilzomib)

EXPERIMENTAL

Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose over 2-10 minutes.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Drug: CarfilzomibDrug: DexamethasoneOther: Laboratory Biomarker Analysis

Interventions

CarfilzomibDRUG

Given IV

Also known as: Kyprolis, PR-171

Arm I (dexamethasone, low-dose carfilzomib)Arm II (dexamethasone, high-dose carfilzomib)

DexamethasoneDRUG

Given IV

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, Visumetazone

Arm I (dexamethasone, low-dose carfilzomib)Arm II (dexamethasone, high-dose carfilzomib)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (dexamethasone, low-dose carfilzomib)Arm II (dexamethasone, high-dose carfilzomib)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

REGISTRATION STEP 1: INITIAL RANDOMIZATION
Patients must have a confirmed diagnosis of symptomatic multiple myeloma and must be currently relapsed or refractory; all tests for establishing disease status must be completed within 28 days prior to registration and documented on the Baseline Tumor Assessment Form for Multiple Myeloma
Patients must have measurable disease within 28 days prior to registration
Patients must have received at least one prior regimen of chemotherapy for symptomatic multiple myeloma; patients may not have more than six (6) previous regimens of therapy for the disease; prior chemotherapy must have been completed at least 21 days prior to registration; for study purposes, a regimen is defined as follows:
An anti-myeloma therapy used at the time of initial diagnosis or documented disease progression which is given with the intent to decrease disease burden
Any maintenance therapy used after an Induction should be considered part of that Induction regimen
Use of any agent or combination of agents more than once during the patient's disease history for separate documented disease progressions will be counted as separate regimens (e.g., if a patient receives lenalidomide/bortezomib at initial diagnosis and achieves response, but then progresses and receives lenalidomide/bortezomib after progression, these count as 2 separate regimens)
In cases of allogeneic or autologous stem cell transplant, the entire induction + stem cell mobilization + conditioning + planned maintenance should be considered one regimen
Patients may not have received any prior carfilzomib treatment
Patients must not be receiving any other concurrent therapy considered to be investigational; patients must not be planning to receive any radiotherapy (except localized radiation for palliative care); patients must not be planning to receive any concurrent chemotherapy, immunotherapy, radiotherapy or other treatment with curative intent
Patients must have complete history and physical examination within 28 days prior to registration
Patients must have baseline PET scan within 28 days prior to registration; note that images are submitted centrally for review
Patients with non-secretory MM or known primary amyloidosis are not eligible
Patients must have Zubrod performance status 0-2
Patients must not have clinically significant illness including uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or \>= grade 3 cardiac arrhythmias
+28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (485)

Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

Location

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

Location

The University of Arizona Medical Center-University Campus

Tucson, Arizona, 85724, United States

Location

Kaiser Permanente-Anaheim

Anaheim, California, 92807, United States

Location

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States

Location

Sutter Auburn Faith Hospital

Auburn, California, 95602, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, 95603, United States

Location

Kaiser Permanente-Baldwin Park

Baldwin Park, California, 91706, United States

Location

Kaiser Permanente-Bellflower

Bellflower, California, 90706, United States

Location

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

Location

Mills - Peninsula Hospitals

Burlingame, California, 94010, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, 95682, United States

Location

Eden Hospital Medical Center

Castro Valley, California, 94546, United States

Location

John Muir Medical Center-Concord Campus

Concord, California, 94520, United States

Location

Sutter Davis Hospital

Davis, California, 95616, United States

Location

Kaiser Permanente Hospital

Fontana, California, 92335, United States

Location

Kaiser Permanente-Fremont

Fremont, California, 94538, United States

Location

Kaiser Permanente

Fresno, California, 93720, United States

Location

Kaiser Permanente - Harbor City

Harbor City, California, 90710, United States

Location

Kaiser Permanente-Irvine

Irvine, California, 92618, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Kaiser Permanente-Cadillac

Los Angeles, California, 90034, United States

Location

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

Location

Memorial Medical Center

Modesto, California, 95355, United States

Location

Kaiser Permanente-Modesto

Modesto, California, 95356, United States

Location

Palo Alto Medical Foundation-Camino Division

Mountain View, California, 94040, United States

Location

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, 94040, United States

Location

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States

Location

Sutter Cancer Research Consortium

Novato, California, 94945, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

Location

Kaiser Permanente - Panorama City

Panorama City, California, 91402, United States

Location

Kaiser Permanente-Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente-Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente-Riverside

Riverside, California, 92505, United States

Location

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

Sutter General Hospital

Sacramento, California, 95816, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

Location

Kaiser Permanente - Sacramento

Sacramento, California, 95825, United States

Location

Kaiser Permanente-San Diego Mission

San Diego, California, 92108, United States

Location

Kaiser Permanente-San Diego Zion

San Diego, California, 92120, United States

Location

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115, United States

Location

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

Location

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

Location

Kaiser Permanente-San Marcos

San Marcos, California, 92069, United States

Location

Kaiser Permanente-San Rafael

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, 95065, United States

Location

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

Location

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente-Stockton

Stockton, California, 95210, United States

Location

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086, United States

Location

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, 95687, United States

Location

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States

Location

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

Location

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

Location

John Muir Medical Center-Walnut Creek

Walnut Creek, California, 94598, United States

Location

Kaiser Permanente

Woodland Hills, California, 91367, United States

Location

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States

Location

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

Location

Medical Oncology and Hematology Group PC-Guilford

Guilford, Connecticut, 06437, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

Location

Smilow Cancer Hospital-Orange Care Center

Orange, Connecticut, 06477, United States

Location

Charlotte Hungerford Hospital Center for Cancer Care

Torrington, Connecticut, 06790, United States

Location

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

Location

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Gynecologic Oncology LLC