Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma
Condition: Extramedullary Plasmacytoma; Isolated Plasmacytoma of Bone; Light Chain Deposition Disease; Primary Systemic Amyloidosis; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial investigates whether patients greater than or equal to 65 years of age
      diagnosed with myeloma or another plasma cell malignancy will have better outcomes with
      transplant followed by maintenance therapy, as primarily measured by progression-free
      survival, versus non-transplant approaches.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To evaluate the progression-free survival (PFS) from the start of dexamethasone,
      cisplatin, Adriamycin (doxorubicin),Cytoxan (cyclophosphamide), etoposide (DPACE) for all
      participants who have had at least one day of protocol treatment.

      II. To evaluate how well such therapy is tolerated in patients mainly over the age of 65
      years by assessing severe complications (intensive care unit [ICU] admission, death) and the
      percentage of participants able to complete the full course of therapy.

      SECONDARY OBJECTIVES:

      I. To evaluate Quality-Of-Life post-transplant using the European Organization for Research
      and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire QLQ-C30 and QLC-MY20.

      OUTLINE:

      INDUCTION THERAPY: Patients receive dexamethasone orally (PO) on days 1-4 and 8-11, cisplatin
      intravenously (IV) continuously, doxorubicin hydrochloride IV continuously, cyclophosphamide
      IV, and etoposide IV on days 1-4. Patients then receive pegfilgrastim subcutaneously (SQ) on
      days 6 and 13 and undergo collection of stem cells when white blood cell (WBC) and cluster of
      differentiation (CD)34 counts are within program range. Following stem cell collection,
      patients may receive interim dexamethasone PO on days 1-4, every 14 days at the discretion of
      the treating physician.

      TRANSPLANT: Beginning between 4 weeks to 6 months after the first day of induction therapy,
      patients receive as transplant conditioning regimen dexamethasone PO on days -4 to -1 and
      days +2 through +5, bortezomib IV bolus on days -4, -1, 2, and 5, thalidomide PO on days -4
      to 5, and melphalan IV on days -4 and -1. Patients undergo autologous peripheral blood stem
      cell transplant (PBSCT) on day 0. Between transplant and consolidation therapy, patients
      receive dexamethasone PO on days 1-4 every 21 days and thalidomide PO daily.

      CONSOLIDATION THERAPY: If administered, post-transplant consolidation may begin 4-6 weeks
      after transplant but should occur no more than 4 months later. Most patients will not receive
      consolidation. Those that do will receive dexamethasone PO on days 1-4 and 8-11, thalidomide
      PO on days 1-11, bortezomib IV on days 1, 4, 8, and 11, cisplatin IV continuously,
      doxorubicin hydrochloride IV continuously, cyclophosphamide IV continuously, and etoposide IV
      continuously on days 1-4.

      MAINTENANCE THERAPY YEAR 1: Beginning 6 weeks-6 months after consolidation therapy or 4 weeks
      to 6 months after transplant if consolidation is skipped, patients receive bortezomib IV
      bolus on days 1, 4, 15, and 18, thalidomide PO QD on days 1-28, and dexamethasone PO on days
      1-4 and 15-18. Treatment repeats every 28 days for up to 12 courses in the absence of disease
      progression or unacceptable toxicity.

      MAINTENANCE THERAPY YEAR 2: Patients receive bortezomib IV on days 1, 4, 15, and 18,
      cyclophosphamide PO or IV on days 1 and 15, and dexamethasone PO QD on days 1, 8, 15, and 22.
      Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed at least once annually at the
      study center, but serum for MM marker results will be sent to the study site for close
      monitoring of PFS .
    

Intervention name(s): dexamethasone; cisplatin; doxorubicin; cyclophosphamide; etoposide; bortezomib; thalidomide; melphalan; autologous stem cell transplant
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): Given PO; Given IV; Given IV; Given IV or PO; Given IV; Given IV; Given PO; Given IV
Other intervention name(s): Aeroseb-Dex; Decaderm; Decadron; DM; DXM; CACP; CDDP; CPDD; DDP; ADM; ADR; Adria; Adriamycin PFS; Adriamycin RDF; CPM; CTX; Cytoxan; Endoxan; Endoxana; EPEG; VP-16; VP-16-213; LDP 341; MLN341; VELCADE; Kevadon; Synovir; THAL; Thalomid; Alkeran; CB-3025; L-PAM; L-phenylalanine mustard; L-Sarcolysin
Intervention MeSH terms: Thalidomide; Dexamethasone; Cyclophosphamide; Melphalan; Doxorubicin; Liposomal doxorubicin; Etoposide; Etoposide phosphate; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment