Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:12/7/2018
Start Date:December 2015

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Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment With Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy

This randomized phase III trial compares ixazomib citrate, lenalidomide, dexamethasone and
zoledronic acid with zoledronic acid alone to see how well they work when given after
radiation therapy in treating patients with solitary plasmacytoma of bone. Ixazomib citrate
may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Lenalidomide may help the immune system kill abnormal blood cells or cancer cells.
Dexamethasone is a drug used in chemotherapy that may cause tumor cells to die. Zoledronic
acid may prevent bone fractures and reduce bone pain, and may also improve survival. Standard
treatment for this cancer is radiation therapy alone. It is not yet known whether ixazomib
citrate, lenalidomide, dexamethasone and zoledronic acid or zoledronic acid alone is more
effective, and whether adding these treatments after radiation therapy is more effective than
radiation therapy alone in treating patients with solitary plasmacytoma of bone.

This phase III randomized clinical trial was designed to assess the impact of the addition of
ixazomib, lenalidomide, and dexamethasone to zoledronic acid the multiple myeloma progression
rate at 5 years. A dynamic allocation procedure will be used to allocate an equal number of
patients to each of the treatment arms. This procedure will balance the number of patients
which falls into each of the following categories between the two treatment arms:

1. % of abnormal plasma cells in the bone marrow: 5-9%

2. age < 60; % of abnormal plasma cells in the bone marrow < 5%; and monoclonal
protein/clonal light chains present in the blood or urine

3. age < 60; % of abnormal plasma cells in the bone marrow < 5% and no monoclonal
protein/clonal light chains present in the blood or urine, (MRD+) minimal residual
disease

4. age ≥ 60; % of abnormal plasma cells in the bone marrow < 5%; and monoclonal
protein/clonal light chains present in the blood or urine

5. age ≥ 60; % of abnormal plasma cells in the bone marrow < 5% and no monoclonal
protein/clonal light chains present in the blood or urine, (MRD+) minimal residual
disease

The primary and secondary objectives are described below.

Primary objective

To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more
promising than zoledronic acid alone in increasing the time before progression to multiple
myeloma.

Secondary objectives

1. To assess changes in minimal residual disease [MRD] by flow cytometry from study entry,
at the completion of treatment, and at 1 year post registration.

2. To assess whether ixazomib, lenalidomide, dexamethasone with zoledronic acid is more
promising than zoledronic acid alone in extending overall survival.

3. To examine the pharmacodynamics effects of treatment on biochemical markers of bone
formation (osteocalcin bone-specific alkaline phosphatase), resorption (serum CTX), and
metabolism (OPG).

Follow-up requirements after documentation of progression to multiple myeloma includes a
maximum of five years following registration.

Pre-registration eligibility criteria (Step 0)

1. Documentation of Disease: Histologic Documentation of Solitary Bone Plasmacytoma

1. For patients pre-registering after the completion of radiation therapy,
documentation of a bone marrow aspirate and biopsy containing <10% clonal plasma
cells done at most 28 days prior to start of radiation therapy

2. For patients pre-registering before the start of radiation therapy, radiation
therapy scheduled to begin at most 28 days after a bone marrow aspirate and
biopsy were performed containing <10% clonal plasma cells

3. Participants must have disease that is measurable by either serum or urine
evaluation of the monoclonal component or by assay of serum free light chains or
by minimal residual detection. Measurable disease is defined as one or more of
the following:

- serum M protein > 0.5 G/DL, or

- urine M protein >200 MG/24H, and/or

- serum FLC assay: involved FLC level > 10 MG/DL with abnormal serum FLC ratio

- ≥ 50 Plasma cells detectable by multicolor flow cytometry, at a sensitive
level of 10^-4

2. Age ≥ 18 years

3. ECOG Performance Status 0-2

Registration Eligibility Criteria (Step 1)

1. Documentation of Disease:

1. No lytic lesions on skeletal survey and whole body PET/CT other than a single
lesion associated with solitary bone plasmacytoma within 28 days prior to
registration.

2. Participants must have disease that is measurable by either serum or urine
evaluation of the monoclonal component or by assay of serum free light chains or
by minimal residual detection. Measurable disease is defined as one or more of
the following:

- serum M protein > 0.5 G/DL, or

- urine M protein >200 MG/24H, and/or

- serum FLC assay: involved FLC level > 10 MG/DL with abnormal serum FLC ratio

- ≥ 50 Plasma cells detectable by multicolor flow cytometry, at a sensitive
level of 10^-4

2. Prior Treatment

1. No major surgery within 21 days of registration with stabilization or resolution
of surgical adverse events.

2. No investigational agent within 21 days prior to registration

3. No ongoing therapy with corticosteroids greater than 10 mg of prednisone or its
equivalent per day. Please note: Inhaled and topical steroids are permitted.

4. No prior proteasome inhibitor or IMiD use.

5. Prior bisphosphonate use is permitted.

6. For all patients:

- Radiation dose should range from 4500 cGy to 6000 cGy

- No treatment for this disease following radiation therapy

- Registration must be completed within 90 days of completion of radiation
therapy.

3. Not pregnant and not nursing, because this study involves an investigational agent
whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn
are unknown and an agent that has known genotoxic, mutagenic and teratogenic effects.

1. Females of childbearing potential (FCBP), defined as a sexually mature female who
1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been
naturally postmenopausal for at least 24 consecutive months that is, has not had
menses at any time in the preceding 24 consecutive months:

- must have a negative serum or urine pregnancy test with a sensitivity of at
least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of
starting lenalidomide.

- must either commit to continued abstinence from heterosexual intercourse or
begin TWO acceptable methods of birth control, one highly effective method
and one additional effective method AT THE SAME TIME, at least 28 days
before she starts taking lenalidomide.

- must agree to ongoing pregnancy testing.

2. Men must agree to use a latex condom during sexual contact with a FCBP even if
they have had a vasectomy.

4. ECOG Performance Status 0-2

5. Required Initial Laboratory Values within 14 days of registration:

1. Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3

2. Platelet Count ≥ 75,000/mm^3

3. Hemoglobin ≥ 10 g/dL

4. Serum Creatinine < 2.0 mg/dL [176.8 µmol/liter]

5. Serum calcium ≤ 11.5 mg/dL

6. Calc. Creatinine Clearance > 50 mL/min

7. Bilirubin ≤ 1.5 x upper limits of normal (ULN)

8. AST ≤ 2.5 x upper limits of normal (ULN)

6. Intercurrent or Recent Illness

1. If history of prior malignancy, subject should be in complete remission for ≥ 5
years at the time of registration (with the exception of basal cell or squamous
cell carcinoma of the skin treated with local resection).

2. HIV + patients are eligible provided they meet the other eligibility criteria
and:

- CD4+ cells are ≥ 250/mm^3

- There is no history of AIDS defining conditions other than historically low
CD4+ cell count.

- The following antiretroviral agents are not allowed: zidovudine, stavudine,
protease inhibitors, combination pills with pharmacologic boosters.

- Recommended antiretroviral regimens to avoid PK interactions include strand
integrase inhibitors with nucleoside and non-nucleoside reverse
transcriptase inhibitors (for example, dolutegravir given with tenofovir and
emtricitabine).

3. Patients with HBV infection are eligible provided they meet the other eligibility
criteria and:

- There is no evidence of hepatic damage related to HBV infection.

- They have had consistently suppressed HBV viral load to undetectable levels
by PCR for a minimum of 12 months.

4. Patients with HCV infection are eligible provided they meet the other eligibility
criteria and:

- They have previously undergone curative therapy and have no evidence of
active HCV infection.

- They have no evidence of liver damage owing to prior HCV infection.

Patients with active HCV infection should be referred for HCV treatment and
standard radiotherapy for the plasmacytoma.

5. Patients cannot have:

- Known allergy to boron or excipients in the formulation.

- Known GI disease or GI procedure that could interfere with the oral
absorption or tolerance of study drugs including difficulty swallowing.

- Infection requiring systemic antibiotic therapy or other serious infection
within 14 days before registration.

- Diarrhea ≥ Grade 1, based on the NCI CTCAE categorization within 14 days of
registration

- Life-threatening illness unrelated to cancer

- The development of erythema nodosum if characterized by a desquamating rash
while taking thalidomide, pomalidomide, or similar drugs.

7. Peripheral Neuropathy: ≤ Grade 2 Peripheral Neuropathy

8. Adequate cardiac function, defined as:

1. No cardiac arrhythmias within 182 days of registration.

2. No congestive heart failure (CHF) within 182 days of registration.

3. No angina or myocardial infarction within 182 days of registration. In view of
potential cardiac risk with lenalidomide, patients with stable angina will be
excluded.

9. Concomitant Treatment: Patients cannot be on systemic treatment with strong inhibitors
of CYP1A2 (fluvoxamine, enoxacin), strong inhibitors of CYP3A (clarithromycin,
telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone) or strong CYP3A
inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital)
within 14 days of registration.

10. QT c< 470 milliseconds (msec) on a 12-lead ECG ≤ 28 days before registration

11. Dental evaluation within 35 days of registration: Complete dental exam; complete
elimination of dental and periodontal pathology including crowns on teeth susceptible
to fracture, extraction of non-restorable or periodontally uncorrectable teeth;
creation of an oral environment that the patient can efficiently maintain in a high
state of health; and oral hygiene instruction to maintain excellent oral health.
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775 South Main Street
Chelsea, Michigan 48118
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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Chelsea, MI
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Principal Investigator: Timothy D. Moore
Phone: 877-779-7585
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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Chillicothe, OH
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Cincinnati, Ohio 45202
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45211
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45230
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45236
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45242
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Clackamas, Oregon 97015
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
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Clackamas, OR
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Clackamas, OR
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5680 Bow Pointe Drive
Clarkston, Michigan 48346
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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Clarkston, MI
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31500 Telegraph Road
Clarkston, Michigan 48346
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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Clarkston, MI
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Clinton Township, Michigan 48038
Principal Investigator: Ding Wang
Phone: 313-916-1784
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Clinton Township, MI
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Clovis, California 93611
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Clovis, CA
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Cody, Wyoming 82414
Phone: 406-238-6290
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Cody, WY
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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Cody, WY
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Coeur d'Alene, ID
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Columbus, Ohio 43213
Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
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Columbus, OH
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810 Jasonway Avenue
Columbus, Ohio 43214
614/442-3130
Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
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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Columbus, Ohio 43222
Principal Investigator: Timothy D. Moore
Phone: 614-234-5433
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Columbus, OH
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5100 W Broad St
Columbus, Ohio 43228
(614) 544-1000
Principal Investigator: Timothy D. Moore
Phone: 614-566-3275
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: Timothy D. Moore
Phone: 614-566-4475
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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111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Principal Investigator: Timothy D. Moore
Phone: 614-566-4475
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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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
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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Coos Bay, Oregon 97420
Principal Investigator: Alison K. Conlin
Phone: 541-269-8392
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Coos Bay, OR
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Crestview Hills, Kentucky 41017
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Crestview Hills, KY
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