None listed
Conditions
Brief summary
The purpose of this study is to determine whether Isatuximab (a new drug), when combined with chemotherapy, improves response to treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are not a candidate for high dose chemotherapy and autologous stem cell transplant. Study Details Eligible participants will receive lenalidomide and dexamethasone (Ld). Participants who have inadequate response to upfront treatment with Ld, will have the addition of Isatuximab. Treatment (each cycle is 28 days) will be given until disease progression, unacceptable toxicity, or withdrawal of consent. Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of Isatuximab in combination with Ld for the treatment of multiple myeloma patients early in the course of their disease.
Interventions
All patients will be given Lenalidomide as oral capsules, 25mg, daily on days 1 to 21 followed by a 7-day rest in a 28-day cycle and Dexamethasone as oral 4mg tablets, at a dose of 40mg (20mg for patients age >75 years) on days 1, 8, 15 and 22 in a 28-day cycle at the start of treatment; patients who are already on Lenalidomide and Dexamethasone (Ld) are still able to be enrolled into the study provided that they have not completed 4 cycles of Ld.
After completion of four cycles of Ld, patients
All patients will be given Lenalidomide as oral capsules, 25mg, daily on days 1 to 21 followed by a 7-day rest in a 28-day cycle and Dexamethasone as oral 4mg tablets, at a dose of 40mg (20mg for patients age >75 years) on days 1, 8, 15 and 22 in a 28-day cycle at the start of treatment; patients who are already on Lenalidomide and Dexamethasone (Ld) are still able to be enrolled into the study provided that they have not completed 4 cycles of Ld. After completion of four cycles of Ld, patients who have not achieved at least a partial response (PR) which will be assessed via a blood sample, will have the addition of Isatuximab. In addition to Ld, Isatuximab is to be administered IV at a dose of 10 mg/kg weekly for the first month, then fortnightly (every 14 days) thereafter. For these patients who remain on Ld, after completion of six cycles of Ld, patients who have not achieved a very good partial response (VGPR) will move onto Isatuximab , Lenalidomide and Dexamaethasone (ILd), whereas patients who have achieved VGPR or greater will remain on Ld. For these patients who remain on Ld, after completion of nine cycles of Ld, patients who have not achieved a complete response (CR) will move onto ILd, whereas patients who have achieved CR or greater will remain on Ld. At any point in time, patients who progress on Ld while on study will also move onto ILd. Treatment will be given until disease progression on ILd or unacceptable toxicity whichever occurs first. Adherence is monitored through hospital drug administration records and tablet adherence through drug packet return.
Sponsors
Australasian Myeloma Research Consortium
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has voluntarily agreed and has given written informed consent to both the main study and the correlative study. 2. Male and Female patients, 18 years or older of age 3. Diagnosed with MM (diagnosis of MM as per IMWG) 4. Measurable M-component in serum or urine, In patients with no detectable M-component, an abnormal FLC ratio on the serum FLC assay 5. No prior therapies (except radiotherapy or short course of corticosteroids equivalent to dexamethasone 160mg in the last 28 days) or have started Ld as first line therapy but not completed cycle 4 of Ld and whose response status is SD or better 6. ECOG performance status 0-2 7. Adequate liver function (ALT, AST and GGT less than or equal to 2.5 x institutional upper limit of normal; GGT less than or equal to'1.5 x institutional upper limit of normal ) 8. CrCl >15ml/min 9. Hb greater than or equal to 80g/L, Platelet count greater than or equal to 75 x 10^9/L, absolute neutrophil count greater than or equal to 1.0 x 10^9/L 10. No contraindication to the use of any of the study drugs 11. Life expectancy of greater than 6 months 12. Patients must be registered on and abide by the Celgene i-access Risk Management Program before receiving first dose of lenalidomide (www.iaccesscelgene.com)
Exclusion criteria
1. Primary amyloidosis 2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 3.Pregnant or lactating women. 4. Known acquired immunodeficiency syndrome (AIDS-related illness) or known HIV disease requiring antiviral treatment, or active hepatitis A, B, or C infection
Outcome results
None listed