Plasma cell leukemia

Carboplatin & Paclitaxel (CP)

CP: Carboplatin & Paclitaxel

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Forde et al. 2022 (CheckMate 816)	2017-2019	Phase 3 (C)	1a. CP & Nivolumab 1b. CVb & Nivolumab 1c. DC & Nivolumab	Inferior EFS

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details. This study was conducted in the United States. The reason for the study was that an unanswered question at the time was whether adding an immune checkpoint inhibitor would improve outcomes.

Biomarker eligibility criteria

• CheckMate 816: No sensitizing EGFR or ALK mutations

Chemotherapy

• Carboplatin (Paraplatin) AUC 5 or 6 IV once on day 1
• Paclitaxel (Taxol) 175 or 200 mg/m² IV once on day 1

21-day cycle for 3 cycles

Subsequent treatment

• Complete resection

References

1. CheckMate 816: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT02998528

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Section editor
	Andrew J. Cowan, MD Seattle, WA LinkedIn

4 regimens on this page 4 variants on this page

First-line therapy

PAD/VCD

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PAD/VCD: PS-341 (Bortezomib), Adriamycin liposomal (Doxorubicin liposomal), Dexamethasone alternating with Velcade (Bortezomib), Cyclophosphamide, Dexamethasone

Regimen

Study	Evidence
Royer et al. 2016	Phase II

Chemotherapy, PAD portion

• Bortezomib (Velcade) 1.3 mg/m² SC once per day on days 1, 4, 8, 11
• Pegylated liposomal doxorubicin (Doxil) 30 mg/m² IV once on day 4
• Dexamethasone (Decadron) 40 mg PO once per day on days 1, 4, 8, 11

Two 21-day cycles (1 & 3), alternating with VCD

Chemotherapy, VCD portion

• Bortezomib (Velcade) 1.3 mg/m² SC once per day on days 1, 4, 8, 11
• Cyclophosphamide (Cytoxan) 300 mg/m² PO once per day on days 1 & 8
• Dexamethasone (Decadron) 40 mg PO once per day on days 1, 4, 8, 11

Two 21-day cycles (2 & 4), alternating with PAD

Responding patients proceeded to undergo high-dose melphalan & autologous hematopoietic stem cell transplant.

References

1. Royer B, Minvielle S, Diouf M, Roussel M, Karlin L, Hulin C, Arnulf B, Macro M, Cailleres S, Brion A, Brechignac S, Belhadj K, Chretien ML, Wetterwald M, Chaleteix C, Tiab M, Leleu X, Frenzel L, Garderet L, Choquet S, Fuzibet JG, Dauriac C, Forneker LM, Benboubker L, Facon T, Moreau P, Avet-Loiseau H, Marolleau JP. Bortezomib, Doxorubicin, Cyclophosphamide, Dexamethasone Induction Followed by Stem Cell Transplantation for Primary Plasma Cell Leukemia: A Prospective Phase II Study of the Intergroupe Francophone du Myélome. J Clin Oncol. 2016 Jun 20;34(18):2125-32. Epub 2016 Apr 25. link to original article contains verified protocol PubMed

Rd

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Rd: Revlimid (Lenalidomide) & low-dose dexamethasone
RevDex: Revlimid (Lenalidomide) & Dexamethasone
Ld: Lenalidomide & low-dose dexamethasone
Len-Dex: Lenalidomide & Dexamethasone

Regimen

Study	Evidence
Musto et al. 2013	Phase II

Chemotherapy

• Lenalidomide (Revlimid) 25 mg PO once per day on days 1 to 21
• Dexamethasone (Decadron) 40 mg PO once per day on days 1, 8, 15, 22

28-day cycle for 4 cycles

Responding patients eligible for transplant proceeded to SCT per center protocol. Responding patients ineligible for transplant received 4 more cycles of Rd, followed by lenalidomide maintenance.

References

1. Musto P, Simeon V, Martorelli MC, Petrucci MT, Cascavilla N, Di Raimondo F, Caravita T, Morabito F, Offidani M, Olivieri A, Benevolo G, Mina R, Guariglia R, D'Arena G, Mansueto G, Filardi N, Nobile F, Levi A, Falcone A, Cavalli M, Pietrantuono G, Villani O, Bringhen S, Omedè P, Lerose R, Agnelli L, Todoerti K, Neri A, Boccadoro M, Palumbo A. Lenalidomide and low-dose dexamethasone for newly diagnosed primary plasma cell leukemia. Leukemia. 2014 Jan;28(1):222-5. Epub 2013 Aug 20. link to original article contains verified protocol PubMed

Consolidation after first-line therapy

Melphalan, then auto HSCT

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Regimen

Study	Evidence
Royer et al. 2016	Phase II

Preceding treatment

• PAD alternating with VCD

Chemotherapy

• Melphalan (Alkeran) 200 mg/m² IV once
  • Patients older than 65 years or with CrCl less than 30 mL/min/1.73m²: 140 mg/m²

References

1. Royer B, Minvielle S, Diouf M, Roussel M, Karlin L, Hulin C, Arnulf B, Macro M, Cailleres S, Brion A, Brechignac S, Belhadj K, Chretien ML, Wetterwald M, Chaleteix C, Tiab M, Leleu X, Frenzel L, Garderet L, Choquet S, Fuzibet JG, Dauriac C, Forneker LM, Benboubker L, Facon T, Moreau P, Avet-Loiseau H, Marolleau JP. Bortezomib, Doxorubicin, Cyclophosphamide, Dexamethasone Induction Followed by Stem Cell Transplantation for Primary Plasma Cell Leukemia: A Prospective Phase II Study of the Intergroupe Francophone du Myélome. J Clin Oncol. 2016 Jun 20;34(18):2125-32. Epub 2016 Apr 25. link to original article contains protocol PubMed

Maintenance after first-line therapy

Lenalidomide monotherapy

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Regimen

Study	Evidence
Musto et al. 2013	Phase II

Preceding treatment

• Rd x 8

Chemotherapy

• Lenalidomide (Revlimid) 10 mg PO once per day on days 1 to 21

28-day cycles until progression

References

1. Musto P, Simeon V, Martorelli MC, Petrucci MT, Cascavilla N, Di Raimondo F, Caravita T, Morabito F, Offidani M, Olivieri A, Benevolo G, Mina R, Guariglia R, D'Arena G, Mansueto G, Filardi N, Nobile F, Levi A, Falcone A, Cavalli M, Pietrantuono G, Villani O, Bringhen S, Omedè P, Lerose R, Agnelli L, Todoerti K, Neri A, Boccadoro M, Palumbo A. Lenalidomide and low-dose dexamethasone for newly diagnosed primary plasma cell leukemia. Leukemia. 2014 Jan;28(1):222-5. Epub 2013 Aug 20. link to original article contains verified protocol PubMed