NCT02916771 · REGISTRY CONDITION SEARCH

Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma

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

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-08-11

This research study is evaluating a new drug called "ixazomib" as a possible treatment for Smoldering Multiple Myeloma.

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

Proportion Of High Risk SMM Patients Who Are Progression Free 2 Years After Receiving IRD Combination Therapy

→

outcome · POSTED

Progression Free Survival

→

outcome · POSTED

Time To Progression

→

outcome · POSTED

Duration of Response

→

outcome · POSTED

Objective Response Rate

→

outcome · POSTED

Overall Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Age ≥ 18 years. * Must meet criteria of high risk smoldering MM based on the criteria described below: * Definition of high-risk SMM: --Bone marrow clonal plasma cells ≥10% and ≤60% and any one or more of the following: * Serum M protein ≥3.0g/dL (IgA, IgG, IgM, or IgD) * IgA SMM * Immunoparesis with reduction of two uninvolved immunoglobulin isotypes * Serum involved/uninvolved free light chain ratio ≥8 (but less than 100) ----Free Light Chain Smoldering Myeloma patients as defined in section 2.4 are not excluded * Progressive increase in M protein level (Evolving type of SMM) ----Increase in serum monoclonal protein by ≥10% on two successive evaluations within a 6 month period * Bone marrow clonal plasma cells 50-60% * Abnormal plasma cell immunophenotype (≥95% of bone marrow plasma cells are clonal) and reduction of one or more uninvolved immunoglobulin isotypes * t (4;14) or del 17p or 1q gain * Increased circulating plasma cells * MRI with diffuse abnormalities or 1 focal lesion * PET-CT with one focal lesion with increased uptake without underlying osteolytic bone destruction * Urine monoclonal light chain excretion ≥500 mg/24 hours * ECOG Performance Status (PS) 0, 1, or 2 (Appendix A) * The following laboratory values obtained ≤ 21 days prior to registration and confirmed prior to the first dose of study drug: * ANC ≥ 1000/uL * PLT ≥ 75,000/uL. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment. * Total bilirubin ≤ 1.5 mg/dL (If total is elevated check direct and if normal patient is eligible.) * AST ≤ 3 x institutional upper limit of normal (ULN) * ALT ≤ 3 x institutional upper limit of normal (ULN) * Calculated creatinine clearance ≥ 30 mL/min * Ability to understand and the willingness to sign a written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Female patients who are postmenopausal for at least 1 year before the screening visit or are surgically sterile. Females of childbearing potential\* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS®) and 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. Female patients must agree to practice two effective methods of birth control from the time of signing the informed consent form though 90 days after the last dose of study drug * A female of childbearing potential is a sexually mature female who: * Has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months) * All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program. * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. * Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy during the entire study treatment period and through 90 days after the last dose of study drug OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.) Exclusion Criteria: * No evidence of CRAB\* criteria or new criteria of active MM which including the following: * Increased calcium levels (corrected serum calcium \>0.25 mmol/dL above the upper limit of normal or \>.275 mmol/dL) related to MM * Renal insufficiency (attributable to MM) * Anemia (Hb 2g/dL below the lower limit of normal or \<10g/dL) related to MM * Bone lesions (lytic lesions or generalized osteoporosis with compression fractures) * Bone marrow plasma cells ≥60% * Serum involved/uninvolved FLC ratio ≥100, provided the absolute level of the involved free light chain is at least 100 mg/L and repeated twice * MRI with two or more focal lesion that is at least 5 mm or greater in size * Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. Prior therapy with bisphosphonate is allowed. Prior radiation therapy to a solitary plasmacytoma is allowed. * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or nursing women will be excluded from the study because lenalidomide is an agent with the potential for teratogenic or abortifacient effects. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixazomib or lenalidomide. * Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. * Major surgery within 14 days before enrollment. * Known Amyloid involvement. * Myeloma-related central nervous system involvement. * Systemic treatment, within 14 days before the first dose of ixazomib with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort. * Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing. * Grade 2 peripheral neuropathy or higher or grade 1 with pain on clinical examination during the screening period. * Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial. * Previous treatment with ixazomib, or participation in a study with ixazomib whether treated with ixazomib or not.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
* Cycles 1-9 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Dexamethasone is administered orally on days 1, 8, 15, 22 on a 28 days cycle * Cycle 10-24 * Ixazomib is administered orally on days 1, 8, 15 on a 28 days cycle * Lenalidomide is administered orally on days 1-21 on a 28 days cycle * Supportive measures consistent with optimal patient care may be given throughout the study
intervention Names
Drug: Ixazomib
Drug: Lenalidomide
Drug: Dexamethasone
label
Ixazomib
type
EXPERIMENTAL

interventions

arm Group Labels
Ixazomib
description
Oral, proteasome inhibitor
name
Ixazomib
other Names
Ninlaro
type
DRUG
arm Group Labels
Ixazomib
description
Oral, immunomodulatory agent
name
Lenalidomide
other Names
Revlimid
type
DRUG
arm Group Labels
Ixazomib
description
Oral, steroid
name
Dexamethasone
other Names
Decadron
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 61
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The proportion of patients who achieve progression free at 2 years will be compared to the rate published for the high risk SMM. By the Mayo Clinic model for risk factors, the median time to progression for patients with high risk SMM was only 1.9 years. Therefore, we assume that, a 2-years progression-free rate of 50% will not be considered promising and a true progression free rate of 75% or higher will be considered promising.
measure
Proportion Of High Risk SMM Patients Who Are Progression Free 2 Years After Receiving IRD Combination Therapy
time Frame
2 years

secondary Outcomes

description
Progression-free survival is defined as the time from protocol therapy initiation to the disease progression or death from any cause, censored at date last known progression free for those who have not progressed or died
measure
Progression Free Survival
time Frame
Time from protocol therapy initiation to the disease progression or death from any cause, censored at date last known progression free for those who have not progressed or died, or up to 60 months post initiation of therapy
description
Time to progression (TTP) is defined as the time from protocol therapy initiation until documented progression, censored at date last known progression-free for those who have not progressed.
measure
Time To Progression
time Frame
The time from protocol therapy initiation until documented progression, censored at date last known progression-free for those who have not progressed or up to 60 months post initiation of therapy
description
Duration of response is defined as the time from objective response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died
measure
Duration of Response
time Frame
time from objective response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died, or up to 60 months post initiation of therapy
description
The objective response rate is defined as partial response or better according to the modified IMWG criteria.
measure
Objective Response Rate
time Frame
2 years
description
Overall survival is defined as the time from protocol therapy initiation to death or date last known alive
measure
Overall Survival
time Frame
Time from protocol therapy initiation to death or date last known alive, or up to 60 months post initiation of treatment

Full study description

brief Summary: This research study is evaluating a new drug called "ixazomib" as a possible treatment for Smoldering Multiple Myeloma.
detailed Description: This research study is a Phase II clinical trial, which tests the effectiveness of an investigational drug(s). The investigational drugs used in this research study are Ixazomib, Lenalidomide and Dexamethasone. "Investigational" means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of Ixazomib, Lenalidomide and Dexamethasone as a treatment regimen for Smoldering Multiple Myeloma. The purpose of this research study is to learn whether the combination of Ixazomib, Lenalidomide, and Dexamethasone works in treating Smoldering Multiple Myeloma. Ixazomib is a drug that may kill or stop cancer cells from growing by blocking the proteasome within the cell, which is responsible for degrading or breaking down a variety of proteins. This type of drug is called a proteasome inhibitor. Lenalidomide is an immunomodulatory drug, meaning it modifies the participant immune system to help fight the participant disease. Dexamethasone is a steroid, which is usually combined with other drugs to enhance their effects to fight the participant disease. Ixazomib is approved by the FDA in combination with Lenalidomide and Dexamethasone for the treatment of Multiple Myeloma and is currently being evaluated for use in the treatment of several types of cancers. Both Lenalidomide and Dexamethasone have been previously approved by the FDA for the treatment of Multiple Myeloma, as well as several other cancers.

Source references

references

citation
Nadeem O, Aranha MP, Redd R, Timonian M, Magidson S, Lightbody ED, Alberge JB, Bertamini L, Dutta AK, El-Khoury H, Bustoros M, Laubach JP, Bianchi G, O'Donnell E, Wu T, Tsuji J, Anderson KC, Getz G, Trippa L, Richardson PG, Sklavenitis-Pistofidis R, Ghobrial IM. Deeper response predicts better outcomes in high-risk-smoldering-myeloma: results of the I-PRISM phase II clinical trial. Nat Commun. 2025 Jan 3;16(1):358. doi: 10.1038/s41467-024-55308-5.
pmid
39753553
type
DERIVED
citation
Nadeem O, Aranha MP, Redd R, Timonian M, Magidson S, Lightbody ED, Alberge JB, Bertamini L, Dutta AK, El-Khoury H, Bustoros M, Laubach JP, Bianchi G, O'Donnell E, Wu T, Tsuji J, Anderson K, Getz G, Trippa L, Richardson PG, Sklavenitis-Pistofidis R, Ghobrial IM. Long-Term Follow-Up Defines the Population That Benefits from Early Interception in a High-Risk Smoldering Multiple Myeloma Clinical Trial Using the Combination of Ixazomib, Lenalidomide, and Dexamethasone. medRxiv [Preprint]. 2024 Apr 19:2024.04.19.24306082. doi: 10.1101/2024.04.19.24306082.
pmid
38699307
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-6fb014d10bc35f45e40f
requested nct id
NCT02916771
primary nct id
NCT02916771
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
51ed3174a2ea16a8a64daa1b0da3bbc9c7413254f4c17c7d50ddfad23a536374
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-6fb014d10bc35f45e40f
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT02916771
occurrences
context exact
NCT02916771
end
11
exact text
NCT02916771
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/344/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
7c2ffd1029ca2f8a4124bd793d4d538fe958c02e76ca8e2af65c59e1052e99eb
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice