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



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2013
Contact:Cara Laubach, MIIM
Email:claubach@swog.org
Phone:210/614-8808

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

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.

PRIMARY OBJECTIVES:

I. To evaluate and compare progression free survival (PFS) of two different doses of
carfilzomib with dexamethasone in multiple myeloma (MM) patients with relapsed and/or
refractory disease.

SECONDARY OBJECTIVES:

I. To evaluate and compare response rates (RR) for each arm. II. To evaluate response rates
(RR) for patients that relapse on low dose carfilzomib and subsequently cross-over to high
dose carfilzomib.

III. To evaluate the safety of this combination for this patient population. IV. To evaluate
overall survival (OS).

TERTIARY OBJECTIVES:

I. To explore the molecular variability in MM cells obtained from extramedullary bone marrow
relapse sites.

II. To explore the role of positron emission tomography (PET) scanning in assessing disease
burden and as a tool to assess treatment response.

III. To explore changes in left ventricular ejection fraction (LVEF) in patients with
relapsed or refractory multiple myeloma treated with low dose carfilzomib or high dose
carfilzomib plus dexamethasone.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive dexamethasone intravenously (IV) and low-dose carfilzomib IV over
2-10 minutes on days 1, 2, 8, 9, 15, and 16. Patients with progression cross-over to Arm II.

ARM II: Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on
days 1, 2, 8, 9, 15, and 16.

Note that for the first course of treatment on both arms carfilzomib is given at a reduced
rate to assess toxicity.

In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years
from initial registration.

Inclusion Criteria:

- 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

- Patients must have undergone an electrocardiogram (EKG) within 28 days prior to
registration

- Patients must have either echocardiogram (ECHO) with ejection fraction >= 45% within
28 days prior to registration

- Patients must not have > grade 2 neuropathy and/or POEMS syndrome (plasma cell
dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes)

- Total bilirubin =< 1.5 x upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
transaminase (SGPT) =< 3 x ULN

- Absolute neutrophil count (ANC) >= 1,000 cell/mm^3 without growth factor support
within 14 days prior to registration

- Platelets >= 50,000 cells/mm^3 for patients who have bone marrow plasmacytosis < 50%
or >= 30,000 cells/mm^3 for patients who have bone marrow plasmacytosis of >= 50%
within 14 days prior to registration

- Calculated or measured creatinine clearance >= 30 ml/min within 14 days prior to
registration

- Patients who are known to be human immunodeficiency virus positive (HIV+) are
eligible providing they meet all of the following additional criteria within 28 days
prior to registration:

- Cluster of differentiation (CD)4 cells >= 500/mm^3

- Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on
combination antiretroviral therapy (cART) or < 25,000 copies HIV mRNA if not on
cART

- No zidovudine or stavudine as part of cART

- Patients who are HIV+ and do not meet all of these criteria are not eligible for
this study

- Patients with known hepatitis B or hepatitis C infection must have viral load <
800,000 IU/L within 28 days prior to registration

- Patients must have baseline skeletal survey to document lytic lesions, osteopenia or
compression fracture within 28 days prior to registration

- Patients may have received palliative external beam radiation therapy (XRT) for local
disease control with no curative intent. XRT must be completed at least 7 days prior
to registration

- Patients must be offered participation in specimen submission for translational
medicine studies and banking; with patient consent, specimens must be submitted

- Patients must not be pregnant or nursing; women/men of reproductive potential must
have agreed to use an effective contraceptive method; a woman is considered to be of
"reproductive potential" if she has had menses at any time in the preceding 12
consecutive months; in addition to routine contraceptive methods, "effective
contraception" also includes heterosexual celibacy and surgery intended to prevent
pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures outlined in the protocol, he/she is
responsible for beginning contraceptive measures

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease free for three years

- Patients or their legally authorized representative must be informed of the
investigational nature of this study and must sign and give written informed consent
in accordance with institutional and federal guidelines

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system

- REGISTRATION STEP 2: CROSSOVER

- Patient must have been eligible for and initially randomized to Arm 1 (low dose
carfilzomib), begun cycle 2 of treatment, and progressed prior to completing 12
cycles of protocol therapy

- At least 14 days and no more than 28 days must have elapsed between the last day of
treatment on Arm 1 and registration to Arm 3

- Patients must have recovered from all non-hematologic toxicities to =< grade 2 and
from all hematologic toxicities to =< grade 3 prior to registration

- Patients must have begun cycle 2 (carfilzomib - 27 mg/m^2) and must not have received
any dose reduction for toxicity in the last cycle of treatment, immediately preceding
progression

- Patients must have serum protein electrophoresis (SPEP) and kappa and lambda light
chain testing performed within 14 days prior to registration in order to establish
baseline measurements

- Patients must not have ejection fraction decrease > 10% from baseline (as determined
by ECHO) or other ejection fraction decrease accompanied by other clinical
signs/symptoms of New York Heart Association (NYHA) class III or IV heart failure,
measured within 28 days prior to registration; if any question exists regarding
individual patient eligibility in this situation, contact the study chair for
determination
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Cody, WY
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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
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Cody, WY
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
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Coeur d'Alene, ID
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5100 W Broad St
Columbus, Ohio 43228
(614) 544-1000
Principal Investigator: John P. Kuebler
Phone: 800-446-5532
Doctors Hospital Nationally recognized for care quality and patient safety and satisfaction, Doctors Hospital is...
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Columbus, OH
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Principal Investigator: John P. Kuebler
Phone: 800-446-5532
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Columbus, OH
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
Principal Investigator: John P. Kuebler
Phone: 800-446-5532
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Columbus, OH
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111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Principal Investigator: John P. Kuebler
Phone: 800-446-5532
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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Columbus, OH
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100 Michigan Street, NE, MC012
Columbus, Ohio 43215
(614) 488-2118
Columbus CCOP As one of the original 20 CCOPs, the Columbus Community Clinical Oncology Program...
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mi
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Columbus, OH
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Columbus, Ohio 43222
Principal Investigator: John P. Kuebler
Phone: 800-446-5532
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Columbus, OH
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810 Jasonway Avenue
Columbus, Ohio 43214
614/442-3130
Principal Investigator: John P. Kuebler
Phone: 800-446-5532
Columbus Oncology and Hematology Associates Inc Columbus Oncology and Hematology Associates is a group of...
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Columbus, OH
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Concord, California 94520
Principal Investigator: Kasra Karamlou
Phone: 925-674-2580
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from
Concord, CA
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Principal Investigator: Patrick J. Flynn
Phone: 952-993-1517
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Coon Rapids, MN
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Crestview Hills, Kentucky 41017
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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mi
from
Crestview Hills, KY
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Danville, Illinois 61832
Principal Investigator: Wenqing Zhang
Phone: 800-446-5532
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from
Danville, IL
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Edward J. Gorak
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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from
Danville, PA
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Davenport, Iowa 52803
Principal Investigator: George Kovach
Phone: 800-446-6088
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from
Davenport, IA
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Davis, California 95616
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from
Davis, CA
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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mi
from
Dayton, OH
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2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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from
Dayton, OH
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9000 N. Main St.
Dayton, Ohio 45415
(937) 734-6784
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Samaritan North Health Center Good Samaritan Hospital (GSH) is passionate about providing the most recent...
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Dayton, OH
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3123 Research Boulevard Suite 150
Dayton, Ohio 45420
(937) 775-1350
Dayton CCOP We are a regional non-profit cancer research consortium serving the Miami Valley area...
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Dayton, OH
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Dearborn, Michigan 48123
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-4673
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Dearborn, MI
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Decatur, Illinois 62526
Principal Investigator: James L. Wade
Phone: 217-876-4740
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from
Decatur, IL
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: James L. Wade
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Decatur, IL
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561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
Principal Investigator: John P. Kuebler
Phone: 800-446-5532
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
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Delaware, OH
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Delaware, Ohio 43015
Principal Investigator: John P. Kuebler
Phone: 614-566-3275
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Delaware, OH
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