Plasma Cell MyelomaPhase 2NCT02619682
Alternating Ixazomib Citrate and Lenalidomide as Maintenance Therapy After Stem Cell Transplant in Treating Patients With Multiple Myeloma
A Phase 2 study testing Ixazomib Citrate, Laboratory Biomarker Analysis and Lenalidomide in people with Plasma Cell Myeloma and Transplant-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies the safety of alternating ixazomib citrate and lenalidomide as treatment to help keep cancer from coming back after stem cell transplant (maintenance therapy) in treating patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Cell Myeloma, Transplant-Related Carcinoma
- What is being tested?
- Ixazomib Citrate, Laboratory Biomarker Analysis and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2015to 24 Oct 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2
- Any autologous patient who underwent high dose melphalan (>= 140 mg/m^2) therapy/peripheral blood stem cell (PBSC) rescue for any stage of multiple myeloma and did not participate in another clinical transplant trial whose primary endpoint is also evaluating long-term, disease-free survival or survival; consenting for study between 30 days to 120 days after transplant; earliest can start therapy is 30 days post transplant after recovered from acute toxicity of autologous stem cell transplant (ASCT)
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care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, OR
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- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form 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 [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
- Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
- Agree to practice effective barrier contraception 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 [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
- Absolute neutrophil count (ANC) >= 1,000/mm^3
- Platelet count (transfusion independent) >= 75,000/mm^3
- Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
- Calculated creatinine clearance >= 30 mL/min
Who cannot join
- Female patients who are lactating or have a positive serum pregnancy test during the screening period
- Failure to have fully recovered (i.e., =< grade 1 toxicity) from the reversible effects of prior ASCT chemotherapy
- Major surgery within 14 days before enrollment
- Radiotherapy within 14 days before enrollment; if the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib
- History of central nervous system multiple myeloma involvement
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
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- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
- Systemic treatment, within 14 days before the first dose of ixazomib, with strong inhibitors of cytochrome P450, family 1, subfamily A, polypeptide 2 gene (CYP1A2) (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of cytochrome P450, family 3, subfamily A gene locus (CYP3A) (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort
- Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent; patient cannot be allergic to boron
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing
- Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
- Patient has >= grade 2 peripheral neuropathy, 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
- Patients with history prior to transplant of progression on lenalidomide therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Alternating the Administration of Ixazomib and Lenalidomide as Maintenance Therapy After Autologous Transplant for Treating Multiple Myeloma
This phase II trial studies the safety of alternating ixazomib citrate and lenalidomide as treatment to help keep cancer from coming back after stem cell transplant (maintenance therapy) in treating patients with multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stimulate the immune system to attack cancer cells. Giving ixazomib citrate and lenalidomide as maintenance therapy after transplant may prolong the length of time until the cancer returns.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the toxicity of the use of ixazomib (ixazomib citrate) and lenalidomide as maintenance therapy after autologous transplant.
SECONDARY OBJECTIVES:
- Evaluate the ability to deliver the planned therapy.
II. Assess initial response to therapy.
III. Evaluate the median time to disease progression.
IV. Assess overall survival.
OUTLINE:
Within 30-120 days after completion of autologous transplant, patients receive ixazomib citrate orally (PO) on days 1, 8 and 15 every 28 days for 2 courses, followed by lenalidomide PO once daily (QD) on days 1-28 for 2 courses. Treatment repeats, alternating after every 2 courses, for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 2 years.
- Conditions
- Plasma Cell Myeloma, Transplant-Related Carcinoma
- Being tested
- Ixazomib Citrate, Laboratory Biomarker Analysis, Lenalidomide
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixazomib CitrateDrug
Also called MLN-9708, MLN9708, Ninlaro
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, Revlimid
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ixazomib citrate and lenalidomide) | Experimental | Within 30-120 days after finishing autologous transplant, patients receive ixazomib citrate PO on days 1, 8 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-28. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients will continue to alternate between ixazomib citrate and lenalidomide every 2 courses for up to 24 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: Ixazomib Citrate; Other: Laboratory Biomarker Analysis; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events, Graded According to CTCAE Version 4.0
Adverse events Toxicity during the 24 months plus one month of post autologous transplant maintenance therapy
Measured: 2 years plus one month
Secondary outcomes (2)
Overall Survival
all MM patients who got post autologous transplant study therapy
Measured: Median 8.6 years from start of therapy
Disease Free Survival
all MM patients who got post autologous transplant study therapy
Measured: Median of 8.6 years from start of study therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start30 Dec 2015
- Primary completion1 Jun 2022
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plasma Cell MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leona Holmberg, Fred Hutchinson Cancer Center
- Investigators
- Leona Holmberg, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619682
- Sponsor's protocol ID
- 9266
- Other IDs
- NCI-2015-01861, X16064, 9266, RG9215039
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2015
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No