Skip to content
Triangle logo TriangleGet started
← Study library

NCT02516423 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
TERMINATED
Registry last update
2026-06-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Symptomatic Myeloma Progression Free-survival (PFS) Rate

→

outcome · POSTED

Changes in Minimal Residual Disease From Study Entry to the Completion of Adjuvant Treatment (Approximately Six Months Post-registration) and at 1 Year Post-registration

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive 4 mg ixazomib by mouth on days 1, 8 and 15. Patients also receive 15 mg lenalidomide by mouth on days 1-21, 12 mg dexamethasone by mouth on days 1, 8, 15, and 22 and zoledronic acid (dose based on creatinine clearance on day 1) IV infusion on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
    intervention Names
    1. Drug: ixazomib
    2. Drug: lenalidomide
    3. Drug: dexamethasone
    4. Drug: zoledronic acid
    label
    ixazomib + lenalidomide + dexamethasone + zoledronic acid
    type
    EXPERIMENTAL
  2. description
    Patients receive zoledronic acid (dose based on creatinine clearance on day 1) IV on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.
    intervention Names
    1. Drug: zoledronic acid
    label
    zoledronic acid
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. ixazomib + lenalidomide + dexamethasone + zoledronic acid
    description
    oral
    name
    ixazomib
    type
    DRUG
  2. arm Group Labels
    1. ixazomib + lenalidomide + dexamethasone + zoledronic acid
    description
    oral
    name
    lenalidomide
    type
    DRUG
  3. arm Group Labels
    1. ixazomib + lenalidomide + dexamethasone + zoledronic acid
    description
    oral
    name
    dexamethasone
    type
    DRUG
  4. arm Group Labels
    1. ixazomib + lenalidomide + dexamethasone + zoledronic acid
    2. zoledronic acid
    description
    IV
    name
    zoledronic acid
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
11
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Symptomatic myeloma PFS is defined as time from randomization to the first instance of criteria for multiple myeloma (MM). MM is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following: * Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11 mg/dL); Renal insufficiency: creatinine clearance \<40 mL per min or serum creatinine \>177 μmol/L (\>2 mg/dL); Anaemia: haemoglobin value of \>20 g/L below the lower limit of normal, or a haemoglobin value \<100 g/L; Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT * Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥60%; Involved:uninvolved serum free light chain ratio ≥100 ; \>1 focal lesions on MRI studies
    measure
    Symptomatic Myeloma Progression Free-survival (PFS) Rate
    time Frame
    18 months
secondary Outcomes
  1. description
    MRD was part of a sub-study which required additional consent and funding. Samples were collected from consenting patients and shipped to Alliance Hematologic Malignancy for release to a central laboratory at the end of the study once funding was obtained.
    measure
    Changes in Minimal Residual Disease From Study Entry to the Completion of Adjuvant Treatment (Approximately Six Months Post-registration) and at 1 Year Post-registration
    time Frame
    at 6 and 12 months post-registration
Full study description
brief Summary
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.
detailed 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: 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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-361ca569c77e0c3e932b
      requested nct id
      NCT02516423
      primary nct id
      NCT02516423
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      61e50ada140f0de9a2f60fe354e5d9fb0b890378e2f30f7ccac890859461779d
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-361ca569c77e0c3e932b
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02516423
      occurrences
      1. context exact
        NCT02516423
        end
        11
        exact text
        NCT02516423
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/81/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      b6c3047c92612c00f2c826bd8325c7836394133b7c4cca86557fdafe9e89a3cf

    Preserved source evidence · Not medical advice