Springfield Clinic | Clinical Research Department
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About
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.
Full description
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:
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
Follow-up requirements after documentation of progression to multiple myeloma includes a maximum of five years following registration.
Enrollment
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Inclusion and exclusion criteria
Pre-registration eligibility criteria (Step 0)
Documentation of Disease: Histologic Documentation of Solitary Bone Plasmacytoma
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
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
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:
Age ≥ 18 years
ECOG Performance Status 0-2
Registration Eligibility Criteria (Step 1)
Documentation of Disease:
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.
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:
Prior Treatment
No major surgery within 21 days of registration with stabilization or resolution of surgical adverse events.
No investigational agent within 21 days prior to registration
No ongoing therapy with corticosteroids greater than 10 mg of prednisone or its equivalent per day. Please note: Inhaled and topical steroids are permitted.
No prior proteasome inhibitor or IMiD use.
Prior bisphosphonate use is permitted.
For all patients:
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.
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:
Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy.
ECOG Performance Status 0-2
Required Initial Laboratory Values within 14 days of registration:
Intercurrent or Recent Illness
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).
HIV + patients are eligible provided they meet the other eligibility criteria and:
Patients with HBV infection are eligible provided they meet the other eligibility criteria and:
Patients with HCV infection are eligible provided they meet the other eligibility criteria and:
Patients with active HCV infection should be referred for HCV treatment and standard radiotherapy for the plasmacytoma.
Patients cannot have:
Peripheral Neuropathy: ≤ Grade 2 Peripheral Neuropathy
Adequate cardiac function, defined as:
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.
QT c< 470 milliseconds (msec) on a 12-lead ECG ≤ 28 days before registration
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.
Primary purpose
Allocation
Interventional model
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11 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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