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RecruitingLast updated: 7 February 2024

FRAIL-M: This phase I/II trial is looking at the most appropriate treatment approaches for patients with newly diagnosed multiple myeloma, taking into consideration patient frailty (weakness)Frailty-stratified, randomised controlled Bayesian adaptive trial of bortezomib versus lenalidomide in transplant-ineligible myeloma (TI-NDMM)

Clinical summary


Eligible patients will be randomised to receive one of the following treatment combinations: (1) Velcade, Lenalidomide and Dexamethasone OR (2) Velcade and Dexamethasone OR (3) Lenalidomide and Dexamethasone. All patients enrolled in the trial will continue to receive treatment until disease progression, unacceptable toxicity or withdrawal of consent.


This trial is treating patients with multiple myeloma


Blood Cancers Haematological





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Trial sponsor

Medical Research Future Fund,Australasian Leukaemia and Lymphoma Group (ALLG)

Scientific Title

Frailty-stratified, randomised controlled Bayesian adaptive trial of bortezomib versus lenalidomide in transplant-ineligible myeloma (TI-NDMM)



1. Male and Female patients, equal to or greater 18 years of age.

2. Symptomatic NDMM as per IMWG criteria

3. Measurable disease as defined by a paraprotein 5g/L and/or an involved light chain isotype 100mg/l with an abnormal kappa:lambda ratio.

4. Not eligible for high-dose melphalan conditioned autologous stem cell transplantation (ASCT) due to age and/or co-morbidities.

5. No contraindication to the use of any of the study drugs.

6. Adequate liver function (total bilirubin less than 2.0x ULN, ALT less than 5.0x ULN) unless considered secondary to MM.

7. Adequate haematological parameters - Hb equal to or greater 80g/L (RBC transfusions as per institutional protocol are allowed); absolute neutrophil count equal to or greater 1.0 x 109/L; and, platelet count equal to or greater 50 x 109/L (equal to or greater 30 x 109/L if MM involvement in the marrow is greater than 50%) without platelet transfusion within 7 days of the screening platelet count.

8. Has provided written informed consent.

9. Women of childbearing potential must have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/mL performed before, during and after treatment.

10. Women of childbearing potential and male subjects who are sexually active with WOCP must agree to use 2 highly effective methods of contraception during the study and for 30 days following the last dose of study treatment including a male condom.


1. Prior treatment for MM apart from localised radiotherapy and/or a short course of steroids (dexamethasone 160mg or equivalent) for emergency management of MM related symptoms.

2. Patients who have had myocardial infarction within 3 months prior to enrolment, or NYHA (New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

3. Creatinine clearance <30ml/min that persists after correction of recognisable reversible factors e.g. hypercalcaemia, dehydration, sepsis etc.

4. Any other serious or uncontrolled medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the completion of treatment according to this protocol.

5. Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency (HIV) positivity.

6. Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.

7. Patient (to whom it is relevant) who is unable or unwilling to meet the requirements of the lenalidomide pregnancy prevention program.

8. Active malignancy with the exception of any of the following:
a. Adequately treated basal cell carcinoma, squamous cell carcinoma or in situ cervical cancer.
b. Adequately treated stage 1 cancer from which the subject is currently in remission from and has been in remission for > 2 years.
c. Stage 1 prostate cancer that does not require treatment.
d. Any other cancer from which the subject has been disease-free for > 2 years.

9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.


  • You have been diagnosed with cancer, but have not received any treatment.


  • 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.

Clinical trials have complex eligibility criteria.

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

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