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RecruitingLast updated: 22 January 2024

KappaMab: 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 MyelomaA 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

Clinical 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.


This trial is treating patients with Multiple Myeloma


Blood Cancers Haematological





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Trial sponsor

Alfred Health

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



Age 18 years and above.

2. Confirmed diagnosis of MM as per IMWG criteria,

3. ECOG performance status 0-2

4. Relapsed and/or refractory kappa restricted MM

5. Received 1-3 prior lines of therapy
a. Induction + ASCT + maintenance = 1 line of therapy
b. (No prior lenalidomide therapy)

6. Adequate liver and kidney function (<2 x institutional upper limit of normal)

7. Platelet count > 75 x 10^9/L, absolute neutrophil count > 1.0 x 109/L

8. No contraindication to the use of KappaMab, lenalidomide or dexamethasone

9. Patient has voluntarily agreed and has given written informed consent.

10. Life expectancy of > 8 weeks

11. Patient must be > 2 weeks from prior chemotherapy, radiotherapy, biological therapy, immunotherapy, major surgery or any other investigational anti-cancer therapy prior to the first dose of study drug

12. All females of childbearing potential (FOCBP)** must agree to have two medically supervised negative pregnancy tests : one at screening, patient undertaking contraceptive controls and one 24 hours prior to dosing of study drug. Patient must use two reliable methods of contraception simultaneously or to practice complete abstinence from any sexual contact during the following time periods related to this study: 1) for at least 28 days before starting study; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method to prevent pregnancy, not plan on conceiving children during or within 6 months following lenalidomide

13. All male participants must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.


Patients with monoclonal gammopathy of uncertain significance.

2. Primary amyloidosis

3. Patients who have received prior allogeneic transplantation

4. Uncontrolled inter-current 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

5. Patients with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma or in situ cancer of the cervix).

6. Pregnant or lactating women.

7. Known hepatitis B, Hepatitis C, HIV infection, other immunosuppressive therapy or autoimmune disease


  • 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 have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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