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Myeloma, Multiple Myeloma Treatments 

Aygün Sahin, MSc, PhD  | CEO and Cancer Lead, Cancer Education and Research Institute (CERI)

FDA approved treatments for Myeloma, Multiple Myeloma 

FDA approvals in 2022
  • February 28, 2022: FDA approved ciltacabtagene autoleucel (Cilta-Cel) CAR-T therapy for relapsed or refractory (heavily pre-treated) multiple myeloma
​The Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (CARVYKTI, Janssen Biotech) for adult patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy. These prior therapies include proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

Ciltacabtagene autoleucel (Cilta-Cel) is a B-cell maturation antigen (BMCA)-directed chimeric antigen receptor (CAR) T-cell therapy. Each dose is customized using a patient’s own T-cells (autologous), collected and genetically modified, and then infused back into the patient’s body.
 
CARVYKTI (Cilta-Cel) side effects:
CARVYKTI label carries a boxed warning for symptoms that can be fatal or life-threatening:
  • Cytokine Release Syndrome (CRS)
  • Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
  • Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
  • Parkinsonism and Guillain-Barré syndrome and their associated complications,
  • Prolonged and/or recurrent cytopenia
 
The most common adverse reactions observed were:
  • Pyrexia,
  • Cytokine release syndrome
  • Hypogammaglobulinemia
  • Musculoskeletal pain
  • Fatigue
  • Infections
  • Diarrhea
  • Nausea
  • Encephalopathy
  • Headache
  • Coagulopathy
  • Constipation
  • Vomiting
 
Study details:
The clinical trial, CARTITUDE-1 (NCT03548207), was an open label, multicenter clinical trial evaluating Cilta-Cel in 97 patients (!) with relapsed or refractory multiple myeloma who received at least three prior lines of therapy and who had disease progression on or after the last chemotherapy regimen. These therapies include:
  • Proteasome inhibitor (PI)
  • An immunomodulatory agent (IMiD)
  • An anti-CD38 monoclonal antibody,
 
Eighty-two (82%) of the patients in the study had received four or more prior lines of anti-myeloma therapy.
 
Patients received ciltacabtagene autoleucel within the range of 0.5‑1.0×106 CAR-positive viable T cells per kg body weight.
 
Study results:
  • The overall response rate (ORR): 97.9% (95% CI: 92.7%, 99.7).
  • The median duration of response (DOR):  95 patients responded to the therapy. The DOR was 21.8 months (95% CI: 21.8, NE) with a median duration of follow up of 18 months.
 
CARVYKTI (Cilta-Cel) dose recommendation:
0.5-1.0×106  CAR-positive viable T-cells per kg of body weight, with a maximum dose of 1×108 CAR-positive viable T-cells per single infusion.
 
CARVYKTI (Cilta-Cel) approval requirements:
  • CARVYKTI is approved with a risk evaluation and mitigation strategy requiring that hospitals and their associated clinics that dispense the therapy must be specially certified to recognize and manage CRS and nervous system toxicities. 
  • To evaluate long-term safety, the FDA is requiring the manufacturer to conduct a post-marketing observational study involving patients treated with Cilta-Cel.
FDA approvals in 2021 
  • February 26, 2021: FDA granted accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma
​The Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have 1) received at least four prior lines of therapy and 2) whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody. 
​Efficacy was evaluated in HORIZON (NCT02963493), a multicenter, single-arm trial.
FDA approvals in 2020 
  • August 5, 2020: FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma
​The Food and Drug Administration (FDA) granted accelerated approval to belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Belantamab mafodotin-blmf was evaluated in DREAMM-2 (NCT 03525678), an open-label, multicenter trial.
  • March 2, 2020: FDA approved isatuximab-irfc for multiple myeloma
I​f you are a multiple myeloma patient and have received at least 2 prior treatments, this might be good news for you! Talk to your doctor. 
​The Food and Drug Administration (FDA) approved isatuximab-irfc (SARCLISA, sanofi-aventis) in combination with pomalidomide and dexamethasone for adults with multiple myeloma who received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. 
#multiplemyeloma #myeloma #fdaapproved #fda #fdaapproval #today #isatuximab #isatuximabirfc #pomalidomide #dexamethasone #lenalidomide #proteasome ​#proteasomeinhibitor #sanofi #sanofiaventis
Resources: 
  1. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-melphalan-flufenamide-relapsed-or-refractory-multiple-myeloma (accessed on March 1, 2021)
  2. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma (accessed on March 1, 2021)
  3. https://www.fda.gov/drugs/development-approval-process-drugs/fda-approves-isatuximab-irfc-multiple-myeloma (accessed on March 2, 2020)
  4. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtagene-autoleucel-relapsed-or-refractory-multiple-myeloma?s=09 (accessed on March 2, 2022)
  5. https://www.fda.gov/media/156560/download (accessed on March 2, 2022)

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