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)

Exclusion

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.