Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This study aims to assess the effectiveness of using a combination of targeted (daratumumab), immunomodulating (lenalidomide) and steroid (dexamethasone) therapies and a stem cell transplant to improve the remission and recurrence rates of Multiple Myeloma in patients that have not responded to the standard induction therapy (Bortezomib). Patients eligible to participate in this study will receive four cycles of daratumumab, lenalidomide and dexamethasone, followed by a stem cell transplant of their own non-cancerous cells and a further 12 cycles of daratumumab, lenalidomide and dexamethasone, with an additional 12 cycles of lenalidomide for maintenance.
Conditions
This trial is treating people with Multiple Myeloma
Eligibility
Inclusion
1. Male and Female patients, greater than or equal to 18 years of age.
2. Symptomatic NDMM as per IMWG criteria
3. Eligible for high-dose melphalan conditioned ASCT.
4. Patients who have had a sub-optimal response to a bortezomib-based induction therapy, where a sub-optimal response is defined as:
The failure to achieve at least a minimal response (MR) with a minimum of 2 cycles of a prior bortezomib-based induction therapy OR a partial response (PR) with 4 cycles of a prior bortezomib-based induction therapy
OR are bortezomib refractory, that is, have progressed while on bortezomib therapy or within 60 days of receiving their last dose of bortezomib.
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. Absolute neutrophil count greater than or equal to 1.0 x 109/L.
8. Platelet count greater than or equal to 50 x 109/L (greater than or equal to 30 x 109/L if MM involvement in the marrow is greater than 50%), patients should not have received platelet transfusions within 7 days of the screening platelet count.
9. Hb greater than or equal to 80g/L, red cell transfusions as per institutional protocol are allowed.
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.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- 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 are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Australiasian Leukaemia and Lymphoma Group (ALLG)
Scientific Title
A multicenter, single arm, study of daratumumab-lenalidomide-dexamethasone (DRd) for newly diagnosed transplant eligible multiple myeloma patients who fail bortezomib-based induction therapy
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