This phase II trial is evaluating an investigational antibody therapy (KappaMab) in combination with lenalidomide (a chemotherapy drug) and dexamethasone (a steroid) for the treatment of relapsed Multiple Myeloma.
This trial is treating patients with Multiple Myeloma.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
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Trial Identifiers
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Scientific Title
A Phase IIb, open label, sequential cohort study comparing KappaMab alone to KappaMab in combination with lenalidomide and low dose dexamethasone (MRd) in Relapsed Refractory Multiple Myeloma
Other Non-Commercial Sponsor
Alfred Health
Summary
The primary purpose of this trial is to evaluate the safety and efficacy of KappaMab in combination with Lenalidomide and Dexamethasone for the treatment of relapsed/refractory multiple myeloma.
Who is it for?
You may be eligible to participate in this trial if you are aged 18 or over with relapsed/refractory kappa restricted multiple myeloma for which you have received Received 1-3 prior lines of therapy.
Study details
Half of the participants in the study will be administered KappaMab only and half will be administered with KappaMab in combination with Lenalidomide and Dexamethasone. KappaMab will be administered weekly for the first eight weeks of study and every 28 days therafter. Lenalidomide will be taken for the first 28 days of study and the first 21 days of cycle 2. Dexamethasone will be taken weekly for the duration of the study. Participants will have blood samples taken once per month 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 a KappaMab and Lenalidomide based immune-oncology approach for the treatment of multiple myeloma patients relatively early in their disease course.
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Not Recruiting Hospitals Read More