Hematopoietic Cell Transplantation RecipientPhase 2NCT01718743
Ixazomib Citrate and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
A Phase 2 study testing Ixazomib Citrate, Lenalidomide and Questionnaire Administration in people with Hematopoietic Cell Transplantation Recipient and Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well ixazomib citrate and lenalidomide after stem cell transplant work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Cell Transplantation Recipient, Plasma Cell Myeloma
- What is being tested?
- Ixazomib Citrate, Lenalidomide and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2012to 12 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient must have undergone autologous stem cell transplantation, with melphalan as a preparative regimen, within 12 months of initiation of induction therapy for newly diagnosed myeloma
- Time to initiation of maintenance therapy; patients may start maintenance therapy as early as 60 days post-transplant and up to 180 days post-transplant; as long as they meet the following criteria:
- Platelet count >= 100,000/mm^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment
- Neutrophil count >= 1000/mm^3; (no growth factors within 5 days prior to first dose of the study drug)
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN
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- Creatinine < 2.5 mg/dL
- Recovered (i.e., =< grade 1 toxicity) from the reversible effects of autologous stem cell transplant
- Patients whose primary therapy was changed due to suboptimal response of toxicity will be eligible, however no more than 2 regimens will be allowed prior to ASCT
- Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
- Voluntary 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, OR if they are childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent, during study treatment and for 90 days after the last dose of study treatment, AND
- Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, 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 treatment, OR
- Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, 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)
Who cannot join
- Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
- Major surgery within 14 days before the first dose of study drug
- 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 MLN9708
- Known active central nervous system involvement
- Systemic treatment, within 14 days before study enrollment, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), 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
- Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment
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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
- Female subject who are lactating or have a positive serum pregnancy test during the screening period
- Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation or completion of treatment according to this protocol
- Corrected QT interval using Bazett's formula (QTcB) > 470 milliseconds (msec) on a 12-lead electrocardiogram (ECG) obtained during the screening period; if a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG
- Ongoing or active systemic infection, known human immunodeficiency virus (HIV) positive, known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations
- Co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of the Combination of MLN 9708 With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma
This phase II trial studies how well ixazomib citrate and lenalidomide after stem cell transplant work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving ixazomib citrate together with lenalidomide may be effective in treating multiple myeloma.
Read the detailed description
PRIMARY OBJECTIVES:
- Establish safety and efficacy of oral ixazomib citrate (MLN 9708) and lenalidomide in the maintenance setting post autologous stem cell transplant (ASCT) in myeloma patients.
SECONDARY OBJECTIVES:
- Incidence of secondary primary malignancy.
II. Evaluate the best response rate (stringent complete response [sCR]/near complete response [nCR]/very good partial response [VGPR]/partial response [PR]).
III. Evaluate time to progression.
IV. Evaluate time to next therapy.
- Evaluate the tolerability and toxicity.
VI. Evaluate M. D. Anderson Symptom Inventory (MDASI)-myeloma symptom evaluation.
OUTLINE:
Beginning 60-180 days post-transplant, patients receive ixazomib citrate orally (PO) on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
- Being tested
- Ixazomib Citrate, Lenalidomide, Questionnaire Administration
- 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
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, Revlimid
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ixazomib citrate, lenalidomide) | Experimental | Beginning 60-180 days post-transplant, patients receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Ixazomib Citrate; Drug: Lenalidomide; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Monitored using the method of Thall et al. Estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Measured: Time from autologous stem cell transplant (ASCT) to time of clinical progression or death or the time of last contact, assessed up to 30 days after completion of study treatment
Secondary outcomes (5)
Best Response Rate (Stringent Complete Response [sCR]/Near Complete Response [nCR]/Very Good Partial Response [VGPR]/Partial Response [PR])
Estimated along with 95% confidence intervals.
Measured: through out study treatment and up to 30 days after completion of study treatment, up to 119 months
Treatment-related Unmanageable Toxicities, Including Grade 3 Non-hematologic Effects, or Grade 4 Hematologic Effects
Toxicity data will be summarized by frequency tables.
Measured: throughout study treatment and up to 30 days after completion of study treatment, up to 119 months
Number of Participants Incidence of New Primary Malignancy
Count of participants
Measured: through out study treatment and up to 30 days after completion of study treatment, up to 119 months
Overall Survival
Estimated using the Kaplan-Meier method. Cox proportional hazards model will be used to include multiple covariates. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Measured: through out study treatment and up to 30 days after completion of study treatment, up to 119 months
M. D. Anderson Symptom Inventory (MDASI)-Myeloma Symptom Evaluation
Analyzed with descriptive analysis. The MDASI-MM scores measure the how severe the symptoms are, so higher scores are considered to be worse patient outcomes. Five subscales are derived from the 26 questions of the MDASI-MM questionnaire:
- mean core (13 MDASI core symptom items), ranges from 0 to 130.
- mean severity (13 MDASI core plus 7 MM-specific items), ranges from 0 to 200.
- mean interference (6 interference items), ranges from 0 to 60.
- mean WAW (interference with work, general activity, and walking), ranges from 0 to 30.
- mean REM (interference with relations with people, enjoyment of life, and mood), ranges from 0 to 30. has context menu
Measured: through out study treatment and up to 30 days after completion of study treatment, up to 119 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study start3 Dec 2012
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
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 Hematopoietic Cell Transplantation RecipientStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Krina Patel, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718743
- Sponsor's protocol ID
- 2012-0277
- Other IDs
- NCI-2012-02873, 2012-0277
- Status last verified
- Jan 2025
- First submitted
- 29 Oct 2012
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Combination of MLN 9708 With Lenalidomide as Maintenance Therapy Post Autologous Stem Cell Transplant in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01718743
- Acronym / sponsor ID
- 2012-0277
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Dec 2012 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well ixazomib citrate and lenalidomide after stem cell transplant work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving ixazomib citrate together with lenalidomide may be effective in treating multiple myeloma.
Detailed description
PRIMARY OBJECTIVES:
- Establish safety and efficacy of oral ixazomib citrate (MLN 9708) and lenalidomide in the maintenance setting post autologous stem cell transplant (ASCT) in myeloma patients.
SECONDARY OBJECTIVES:
- Incidence of secondary primary malignancy.
II. Evaluate the best response rate (stringent complete response [sCR]/near complete response [nCR]/very good partial response [VGPR]/partial response [PR]).
III. Evaluate time to progression.
IV. Evaluate time to next therapy.
- Evaluate the tolerability and toxicity.
VI. Evaluate M. D. Anderson Symptom Inventory (MDASI)-myeloma symptom evaluation.
OUTLINE:
Beginning 60-180 days post-transplant, patients receive ixazomib citrate orally (PO) on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ixazomib citrate, lenalidomide) | Experimental | Drug: Ixazomib Citrate, Drug: Lenalidomide, Other: Questionnaire AdministrationBeginning 60-180 days post-transplant, patients receive ixazomib citrate PO on days 1, 8, and 15 and lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient must have undergone autologous stem cell transplantation, with melphalan as a preparative regimen, within 12 months of initiation of induction therapy for newly diagnosed myeloma
- Time to initiation of maintenance therapy; patients may start maintenance therapy as early as 60 days post-transplant and up to 180 days post-transplant; as long as they meet the following criteria:
- Platelet count >= 100,000/mm^3; platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment
- Neutrophil count >= 1000/mm^3; (no growth factors within 5 days prior to first dose of the study drug)
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
Key exclusion criteria (15 listed)
- Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
- Major surgery within 14 days before the first dose of study drug
- 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 MLN9708
- Known active central nervous system involvement
- Systemic treatment, within 14 days before study enrollment, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ixazomib CitrateAlso: MLN-9708, MLN9708, NinlaroGiven PO | Drug | Treatment (ixazomib citrate, lenalidomide) |
| LenalidomideAlso: CC-5013, CC5013, CDC 501, RevlimidGiven PO | Drug | Treatment (ixazomib citrate, lenalidomide) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (ixazomib citrate, lenalidomide) |
Primary outcome
Progression-free Survival
Time frame: Time from autologous stem cell transplant (ASCT) to time of clinical progression or death or the time of last contact, assessed up to 30 days after completion of study treatment
Monitored using the method of Thall et al. Estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
5 secondary outcomes
Best Response Rate (Stringent Complete Response [sCR]/Near Complete Response [nCR]/Very Good Partial Response [VGPR]/Partial Response [PR])
Time frame: through out study treatment and up to 30 days after completion of study treatment, up to 119 months
Treatment-related Unmanageable Toxicities, Including Grade 3 Non-hematologic Effects, or Grade 4 Hematologic Effects
Time frame: throughout study treatment and up to 30 days after completion of study treatment, up to 119 months
Number of Participants Incidence of New Primary Malignancy
Time frame: through out study treatment and up to 30 days after completion of study treatment, up to 119 months
Overall Survival
Time frame: through out study treatment and up to 30 days after completion of study treatment, up to 119 months
M. D. Anderson Symptom Inventory (MDASI)-Myeloma Symptom Evaluation
Time frame: through out study treatment and up to 30 days after completion of study treatment, up to 119 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krina Patel principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixazomib Citrate, Lenalidomide and Questionnaire Administration in people with Hematopoietic Cell Transplantation Recipient and Plasma Cell Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: Time from autologous stem cell transplant (ASCT) to time of clinical progression or death or the time of last contact, assessed up to 30 days after completion of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.