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AzTrials

Multiple MyelomaPhase 2NCT02586038

STUDY THAT COMPARE 3 ARM: MLN9708 DEXAMETHASONE, MLN9708 CYCLOPHOSPHAMIDE AND DEXAMETHASONE, MLN9708 THALIDOMIDE AND DEXAMETHASONE FOLLOWED BY MAINTENANCE WITH MLN9708 IN NEWLY DIAGNOSED ELDERLY MULTIPLE MYELOMA PATIENTS

A Phase 2 study testing MLN9708, Dexamethasone and Cyclophosphamide in people with Multiple Myeloma, run by Mario Boccadoro at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the safety and the efficacy of the MLN-DEXAMETHASONE, MLN-DEXAMETHASONE-CYCLOPHOSPHAMIDE, or MLN- THALIDOMIDE-DEXAMETHASONE induction combinations, followed by MLN maintenance in newly diagnosed elderly Multiple Myeloma patients. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
MLN9708, Dexamethasone and Cyclophosphamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
1 siteItaly
Study dates
Oct 2015to Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
  • Patient has given 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  • Female patient is either post-menopausal or surgically sterilized or willing to use two acceptable methods of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
  • Newly diagnosed MM based on standard CRAB criteria (see Appendix 12.2).
  • Age ≥ 65 years old or younger not eligible for transplantation.
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  • Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein (M-protein) value (, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results
  • Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2
  • Clinical laboratory values within 30 days of enrolment:
  • platelet count ≥ 75 x 109/L (Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment)
  • haemoglobin ≥ 8 g/dL
  • absolute neutrophil count (ANC) ≥ 1.0 x109/L
  • AST and ALT ≤ 3 times the upper limit of normal
  • total bilirubin ≤ 1.5 times the upper limit of normal
  • clearance creatinine ≥ 30 ml/min

Who cannot join

  • Pregnant or lactating females.
  • Serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from the enrolment or place the subject at unacceptable risk.
  • Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid < to the equivalent of dexamethasone 40 mg/day for 4 days)
  • Clinical active infectious hepatitis type A, B, C or HIV (HBV-DNA and HCV-RNA will be analysed to evaluate the cell proliferation of virus; anti-HIV antibody must be negative).
  • Acute active infection requiring antibiotics or infiltrative pulmonary disease
  • Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.03
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  • Contraindication to any of the required drugs or supportive treatments
  • Invasive malignancy within the past 3 years
  • Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort within 14 days before the first dose of study treatment (see Appendix 12.12).
  • Diagnosis of Waldenstrom's macroglobulinemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
  • 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.
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations.
  • Female patients who are lactating or have a positive serum pregnancy test during the screening period.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • AO SS Antonio e Biagio e Cesare Arrigo di Alessandria

    Alessandria, 15121

Other trials in Italy

About this study

Official title: A MULTIARM, OPEN LABEL, RANDOMIZED PHASE II STUDY OF MLN9708 PLUS ORAL DEXAMETHASONE or PLUS ORAL CYCLOPHOSPHAMIDE AND DEXAMETHASONE or PLUS ORAL THALIDOMIDE AND DEXAMETHASONE FOLLOWED BY MAINTENANCE WITH MLN9708 IN NEWLY DIAGNOSED ELDERLY MULTIPLE MYELOMA PATIENTS

This study will evaluate the safety and the efficacy of the MLN-DEXAMETHASONE, MLN-DEXAMETHASONE-CYCLOPHOSPHAMIDE, or MLN- THALIDOMIDE-DEXAMETHASONE induction combinations, followed by MLN maintenance in newly diagnosed elderly Multiple Myeloma patients.

183 patients, males and females, older than 65 years old or younger but considered not eligible for high-dose chemotherapy and transplantation, enrolled in different sites, will take part in this study.

The duration of the study is approximately 5 years.

Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02586038
Study groupRoleWhat they receive
MLN-DEX-CYCLO armExperimentalPatients will receive nine 28-days induction cycles. MLN9708: 4,0 mg orally on days 1, 8, 15 Dexamethasone: 40 mg orally on days 1, 8, 15, 22. Cyclophosphamide: 300 mg/sqm orally on days 1, 8, 15
Receives: Drug: MLN9708; Drug: Dexamethasone; Drug: Cyclophosphamide
MLN-DEX-THAL armExperimentalPatients will receive nine 28-days induction cycles. MLN9708: 4,0 mg orally on days 1, 8, 15 Dexamethasone: 40 mg orally on days 1, 8, 15, 22. Thalidomide: 100 mg/day orally
Receives: Drug: MLN9708; Drug: Dexamethasone; Drug: Thalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Number of patients that will experience a progression disease after 2 years from diagnosis in 3 induction treatments, followed by maintenance with MLN9708, including:

    • MLN9708 plus dexamethasone (MLN-DEX)
    • MLN9708 plus dexamethasone and cyclophosphamide (MLN-CYCLO-DEX)
    • MLN9708 plus dexamethasone and thalidomide (MLN-THAL-DEX) A maximum of 61 patients per arm will be evaluated.

    Measured: 2 years

Secondary outcomes (6)

  1. Response rate

    Response rate will evaluate efficacy in terms of Very Good Partial Remission (VGPR) of the 3 induction treatments, followed by maintenance with MLN9708. Rate of VGPR will be evaluated after cycle 4. Responses will be evaluated after each cycle.

    A maximum of 61 patients per arm will be evaluated.

    Measured: 5 years

  2. Toxicity in terms of rate of hematologic and non-hematologic adverse events

    Safety of combination will be evaluated in terms of rate of hematologic and non-hematologic adverse events of the 3 induction treatments, followed by maintenance with MLN9708. Toxicity will be evaluated according to the NCI CTCAE, version 4.03.

    A maximum of 61 patients per arm will be evaluated.

    Measured: 5 years

  3. Progression Free Survival-2 (PFS-2)

    Time from randomization to the date of first observation of second disease progression or death to any cause in each induction treatments A maximum of 61 patients per arm will be evaluated.

    Measured: 5 years

  4. Time To Progression (TTP)

    Time from the date of randomization to the date of first observation of progression, or deaths related to progression of the 3 induction treatments, followed by maintenance with MLN9708 A maximum of 61 patients per arm will be evaluated.

    Measured: 5 years

  5. Time to Next Therapy (TNT)

    Time from the date of randomization to the date of next anti-myeloma therapy of the 3 induction treatments, followed by maintenance with MLN9708 A maximum of 61 patients per arm will be evaluated.

    Measured: 5 years

  6. Explorative comparative analyses

    Explorative comparative analyses will be performed between the three arms and by in subgroups of patients, defined according to known prognostic factors A maximum of 61 patients per arm will be evaluated.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2023
  4. Study completionDec 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
175 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02586038
Sponsor's protocol ID
UNITO-EMN10
Status last verified
May 2024
First submitted
21 Oct 2015
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MLN9708, Dexamethasone and Cyclophosphamide in people with Multiple Myeloma, run by Mario Boccadoro at 1 site in Italy.

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 15 inclusion and 13 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 8 May 2024. 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02586038.

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 8 May 2024.

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