MM21: This study evaluates the effectiveness of using a combination of therapies (Daratumumab-lenalidomide-dexamethasone) with stem cell transplant to treat patients diagnosed with Multiple Myeloma who have not responded to standard treatmentA multicenter, single arm, study of daratumumab-lenalidomide-dexamethasone (DRd) for newly diagnosed transplant eligible multiple myeloma patients who fail bortezomib-based induction therapy

Exclusion

1. Patients who have had myocardial infarction within 6 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.
2. 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.
3. Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency (HIV) positivity.
4. Subject has significant airways disease according to the following definitions:
a. Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal.
b. Subject has had known moderate or severe persistent asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
5. Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.
6. Any patient who is unable or unwilling to meet the requirements of the lenalidomide pregnancy prevention program.
7. 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 greater than 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 greater than 2 years.
8. 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.
9. Participation in other clinical trials for the treatment of multiple myeloma, 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.