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New hope for myeloma patients Who've run out of options?

NCT ID NCT02461888

Disease control Sponsor: University of Leeds Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a three-drug combination (ixazomib, cyclophosphamide, and dexamethasone) in 112 patients with multiple myeloma that had returned or stopped responding to three previous treatments. The goal was to see if adding ixazomib to standard chemotherapy could help control the disease longer. The study is now complete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ixazomib, cyclophosphamide, and dexamethasone
What this could lead to
If successful, this could offer a new treatment option for multiple myeloma patients who have stopped responding to other therapies.
What could go wrong
This is a phase 2 trial with only 112 participants, so results are preliminary. The combination may not work better than existing treatments and could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

112 people

The number who actually took part.

Started

Dec 2015

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able to give informed consent and willing to follow study protocol assessments * Aged 18 years or over * Participants with confirmed multiple myeloma based on International Myeloma Working Group (IMWG) criteria, 2009 * Measurable disease * Participants with relapsed or relapsed refractory myeloma and now require further treatment following exposure to thalidomide, lenalidomide and bortezomib regardless of response to these * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 * Required laboratory values within 14 days prior to Randomisation: * Platelet count ≥50x109/L. Platelet support is permitted within 14 days prior to Randomisation * Absolute neutrophil count ≥1.0 x 109/L * Haemoglobin \> 9 g/dL. Blood support is permitted * Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST) ≤3 x upper limit of normal * Creatinine clearance ≥ 30 ml/min (using Cockcroft Gault formula) * Bilirubin ≤1.5 x upper limit of normal * Both non-sterilised and sterilised females and males of reproductive age should use effective methods of contraception during the entire trial treatment (including treatment breaks) and up to 90 days after the last dose of trial treatment * Post allograft patients may be included Exclusion Criteria: * Those with non-measurable disease * Those with a solitary bone or solitary extramedullary plasmacytoma * Plasma cell leukaemia * Prior malignancy other than those treated with curative surgery. * Participants with a known or underlying uncontrolled concurrent illness that, in the investigators opinion, would make the administration of the study drug hazardous or circumstances that could limit compliance with the study * Patients who have previously received MLN9708/Ixazomib in a trial. Previous experimental agents or approved anti-tumour treatment within 30 days before the date of randomisation. * A maximum of 160mg of dexamethasone (in 40mg blocks) may be given between screening and the beginning of treatment if medically required but should be stopped before trial treatment starts. Bisphosphonates for bone disease and radiotherapy for palliative intent are also permitted * Participants with a history of a refractory nausea, diarrhoea, vomiting, malabsorption, gastrointestinal surgery or other procedures that might, in the opinion of the Investigator, interfere with the absorption or swallowing of the study drug(s) * Peripheral neuropathy of ≥ grade 2 severity * Gastrointestinal disorders that may interfere with absorption of the study drug * Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B or C) hepatitis * Female patients who are lactating or have a positive serum pregnancy test during the screening period * Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent * Systemic treatment, within 14 days before the first dose of MLN9708, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of 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 * Major surgery within 14 days prior to the date of randomisation * Radiotherapy within 14 days prior to randomisation * Disease involving the Central Nervous System

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • Barts and the London NHS Trust

    London, E1 1BB, United Kingdom

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Guy's and St Thomas's NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • Heart of England NHS Foundation Trust

    Birmingham, B9 5ST, United Kingdom

  • Imperial College Healthcare NHS Trust

    London, W2 1NY, United Kingdom

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF, United Kingdom

  • North Tees and Hartlepool NHS Foundation Trust

    Hartlepool, TS24 9AH, United Kingdom

  • Nottingham University Hospital NHS Trust

    Nottingham, NG7 2UH, United Kingdom

  • Queen Elizabeth Medical Centre

    Birmingham, B15 2TH, United Kingdom

  • Royal Bournemouth General Hospital

    Bournemouth, BH7 7DW, United Kingdom

  • Royal Liverpool and Broadgreen University Hospital NHS Trust

    Liverpool, L7 8XP, United Kingdom

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S5 7AU, United Kingdom

  • Southampton University Hospital NHS Trust

    Southampton, SO16 6YD, United Kingdom

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Royal Wolverhampton Hospital NHS Trust

    Wolverhampton, WV10 0QP, United Kingdom

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG, United Kingdom

  • University Hospital Bristol NHS Foundation Trust

    Bristol, BS1 3NU, United Kingdom

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