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RecruitingLast updated: 17 June 2024

ALLG MM23: This phase III trial is comparing the use of an oral cancer drug (Lenalidomide) alone and in combination with chemotherapy (Selinexor) and a corticosteroid (Dexamethasone) in patients with newly diagnosed multiple myeloma who are currently undergoing Autologous stem cell transplantAn ALLG phase 3 randomised trial of Selinexor and Lenalidomide-dexamethasone versus lenalidomide maintenance post Autologous stem cell transplant for patients with Newly Diagnosed multiple myeloma

Clinical summary

Summary

Participants in this study will be randomised to receive either:

  • Lenalidomide 10mg, orally, once a day for 21 days; or
  • Lenalidomide 10mg, orally, once a day for 21 days with Selinexor 40mg, orally, weekly

Lenalidomide may be increased to 15mg orally, once a day for 21 days from Cycle 4 onwards, provided good tolerance and no Lenalidomide-related greater than or equal to grade 3 adverse events.

Selinexor may be maintained at 40mg orally, weekly, from Cycle 2 onwards provided good tolerance and no Selinexor-related greater than or equal to grade 3 adverse events. Each cycle lasts 28 days.

During the trial, participants will have blood tests performed and bone marrow samples taken to help determine the progress of the treatment.

Conditions

This trial is treating patients with multiple myeloma

Cancer

Blood Cancers Haematological

Age

People17+

Phase

III

Trial Acronym

ALLG MM23

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Australasian Leukaemia and Lymphoma Group (ALLG)

Scientific Title

An ALLG phase 3 randomised trial of Selinexor and Lenalidomide-dexamethasone versus lenalidomide maintenance post Autologous stem cell transplant for patients with Newly Diagnosed multiple myeloma

Eligibility

Inclusion

• Patient must be 18 years of age or older
• Patient has voluntarily agreed and has given written consent to both the main study and
correlative study
• Diagnosis of MM as per IMWG guidelines (Appendix 3)
• Must be eligible for front-line melphalan conditioned ASCT
• Will have undergone at least 3-6 cycles of up-front therapy containing a proteasome
inhibitor (PI) and/or immunomodulatory drug (IMID) and ASCT (tandem transplants
allowable) prior to screening procedures (note consent and registration will occur prior to
ASCT
• Pre-ASCT (preferably prior to and if not, as early as possible during induction therapy)
bone marrow aspirate trephine for correlative studies. Patients who are unable to provide
pre ASCT BMAT samples for correlative studies can be enrolled into the study if a waiver
is granted from the coordinating principal investigator
• Measurable disease at diagnosis:
• Serum M-protein greater than or equal to 5 g/L, or
• Urine M-protein greater than or equal to 200 mg/24 hour, or
• In patients without measurable serum or M-protein, serum free light chain (SFLC)
greater than 100mg/L (involved light chain) and an abnormal serum k/l ratio or
• In IgA patients whose disease can only be reliably measured by serum quantitative
immunoglobulin (qIgA) greater than or equal to 7500 mg/L (7.5 g/L).
• Female patients who are postmenopausal for at least 1 year prior to screening visit OR
surgically sterile OR agree to practice 2 effective methods of contraception at the same
time from 4 weeks before start of study treatment and until 90 days after the last dose of
study drugs OR agree to practice true abstinence when this is in line with the preferred
and usual lifestyle of the subject.
• Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to
practice effective barrier contraception during the entire study treatment period and
through 90 days after the last dose of study drug, OR to practice true abstinence when
this is in line with the preferred and usual lifestyle of the subject.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix 2).
• Subjects must agree not to donate blood, semen or sperm while on study and at least 90
days after treatment discontinuation.
• Subjects must agree not to share their medication and to return unused supplies.
• Patients must meet the following clinical laboratory criteria:
o Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L and platelet count
greater than or equal to 100 x10^9/L. Platelet transfusions to help patients meet
eligibility criteria are not allowed.
o Total bilirubin less than or equal to 1.5 x the upper limit of the normal range (ULN)
o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal
to 3 x ULN.
o Calculated creatinine clearance greater than or equal to 30 mL/min per Cockcroft-Gault
equation.

Exclusion

• Pregnant or lactating women.
• Failure to have fully recovered (i.e. less than or equal to Grade 1 toxicity) from the
reversible effects of prior chemotherapy.
• Progressive disease post-ASCT.
• Major surgery within 14 days before enrolment.
• Radiotherapy within 14 days before enrolment. If the involved field is small, 7 days will be
considered a sufficient interval between treatment and administration of the selinexor.
• Central nervous system involvement.
• Active infection requiring iv antibiotics in 5 days prior to starting study therapy.
• Subjects with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B
has been given for >8 weeks and viral load is <100 IU/ml prior to first dose of trial
treatment. Subjects with untreated hepatitis C virus (HCV) are not allowed. Subjects with
Human Immunodeficiency Virus (HIV) who have CD4+ T-cell counts greater than or equal
to 350 cells/µL and no history of AIDS-defining opportunistic infections in the last year are
allowed.
• Any serious medical or psychiatric condition (including uncontrolled infection) that could,
in the investigator’s opinion, potentially interfere with the completion of treatment
according to this protocol or would be a contraindication to consolidation/maintenance
therapy.
• Known allergy to any of the study medications, their analogues, or excipients in the
various formulations of any agent.
• Known GI disease or GI procedure that could interfere with the oral absorption or
tolerance of study medications including difficulty swallowing.
• Patient has greater than or equal to 2 grade peripheral neuropathy or grade 1 with pain on
clinical examination during the screening period.
• Participating 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.
• Contraindication to the use of either lenalidomide or selinexor.

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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