AMaRC 03-16: This phase II trial is assessing an induction therapy (VCD) alone and with daratumumab maintenance (VCDD) as a treatment alternative for Multiple Myeloma patients who are unable to receive a transplantA Randomised phase 2 study of bortezomib, cyclophosphamide and dexamethasone induction (VCD) compared with VCD and daratumumab maintenance (VCDD) for the initial treatment of transplant ineligible patients with multiple myeloma

Exclusion

1. Patients with Amyloid light-chain (AL) amyloidosis, monoclonal gammopathy of uncertain significance or smouldering MM.
2. Female patients who are lactating or have a positive serum pregnancy test during the screening period.
3. Patient has greater than or equal to Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
4. Subject has significant airways disease according to the following definitions:
a. Subject has known chronic obstructive pulmonary disease (COPD) with an Forced Expiratory Volume in 1 second (FEV1) less than 50 percent 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. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, New York Heart Association (NYHA) class 3 or 4 heart failure symptoms, unstable angina, or myocardial infarction within the past 6 months.
6. Known ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive
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 I cancer from which the subject is currently in remission and has been in remission for 2 years
c. Stage I prostate cancer that does not require treatment
d. Any other cancer from which the subject has been disease-free for greater than or equal to 2 years
8. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
9. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
10. 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.