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NCT01849783 · REGISTRY CONDITION SEARCH

Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2022-05-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Median Progression Free Survival (mPFS)

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outcome · POSTED

Percentage of Participants With Serious Treatment-Related Complications

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outcome · POSTED

Percentage of Participants Able to Complete Full Course Therapy

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outcome · POSTED

Mean Change in Quality-Of-Life Indicators Post-Transplant

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Participants must have had a diagnosis of symptomatic multiple myeloma (MM), MM + amyloidosis, or POEMS (osteosclerotic myeloma: polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) requiring treatment; participants with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy; Note that study participants do not need to have active disease at the time of study entry, as participants may have received up to 12 months of prior chemotherapy, which might have induced a response * Protein criteria must be present at diagnosis (quantifiable M-component of IgG, IgA, IgD, or IgE and/or urinary kappa or lambda light chain, Bence-Jones protein, or Free Kappa Light Chain or Free Lambda Light Chain) in order to evaluate response. Non-secretory participants are eligible provided the participant has \> 20% plasmacytosis OR multiple (≥3) plasmacytomas or lesions on MRI at the time of diagnosis or study enrollment , OR the presence of lesions on PET/CT scan or skeletal survey at diagnosis or study enrollment. * Participants must have received ≤12 months of prior chemotherapy for this disease without evidence of progressive disease with treatment. Participants may have received prior radiotherapy provided approval has been obtained from the PI. Participants with a history of radiation who have a platelet count \<150,000 due to radiation (disease, chemo, and other factors have been ruled out) will be excluded from this study. * Participants must not have had a prior transplant * Participants must be 65-85 years of age at the time of study entry. * Ejection fraction by echocardiogram (ECHO) or multigated acquisition scan (MUGA) of \>= 40% performed * Participants must have adequate pulmonary function studies (PFTs), \>= 50% of predicted on mechanical aspects (forced expiratory volume in 1 second \[FEV\^1}, forced vital capacity \[FVC\]) and diffusion capacity (diffusion capacity of the lung for carbon monoxide \[DLCO\]) \>= 50% of predicted (adjusted for hemoglobin); if the participant is unable to complete pulmonary function tests (PFTs) due to disease-related pain or other circumstances that make it difficult to reliably perform PFTs, documentation of pulmonary function adequate for transplant will occur via a CT scan without evidence of major pulmonary disease, and arterial blood gas results * Participants must have a creatinine \< 3 mg/dl and a GFR \>30mL/min/1.73m2 * Participants must have a performance status of 0-2 based on Eastern Cooperative Oncology Group (ECOG) criteria; participants with a poor performance status (3-4) based solely on bone pain will be eligible, provided there is documentation to verify this * Participants must sign the most current institutional review board (IRB)-approved study (informed consent form) ICF Exclusion Criteria: * Prior autologous or allogeneic transplant * Progressive disease on prior treatment * Platelet count \< 30 x 10\^9/L, unless myeloma-related; if MM-related (hypercellular marrow biopsy of \> 80% and packed with at least 80% plasma cells) the enrolling investigator must document this * \> Grade 3 neuropathy * Known hypersensitivity to bortezomib, boron, or mannitol * Uncontrolled diabetes on appropriate therapy * Recent (=\< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension on appropriate therapy, or difficult-to-control cardiac arrhythmias * Participants must not have a creatinine \>3 mg/dl or a GFR \<30mL/min/1.73m2. * Participants must not have a concurrent malignancy unless it can be adequately treated by non-chemotherapeutic intervention; participants may have a history of prior malignancy, provided that he/she has not had any chemotherapy within 365 days of study entry AND that life expectancy exceeds 5 years at the time of study entry * Participants must not have life-threatening co-morbidities
healthy Volunteers
false
maximum Age
85 Years
minimum Age
65 Years
sex
ALL
std Ages
  1. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.
    intervention Names
    1. Drug: dexamethasone
    2. Drug: cisplatin
    3. Drug: doxorubicin
    4. Drug: cyclophosphamide
    5. Drug: etoposide
    6. Drug: bortezomib
    7. Drug: thalidomide
    8. Drug: melphalan
    9. Procedure: autologous stem cell transplant
    label
    autologous stem cell transplant
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. autologous stem cell transplant
    description
    Given PO
    name
    dexamethasone
    other Names
    1. Aeroseb-Dex
    2. Decaderm
    3. Decadron
    4. DM
    5. DXM
    type
    DRUG
  2. arm Group Labels
    1. autologous stem cell transplant
    description
    Given IV
    name
    cisplatin
    other Names
    1. CACP
    2. CDDP
    3. CPDD
    4. DDP
    type
    DRUG
  3. arm Group Labels
    1. autologous stem cell transplant
    description
    Given IV
    name
    doxorubicin
    other Names
    1. ADM
    2. ADR
    3. Adria
    4. Adriamycin PFS
    5. Adriamycin RDF
    type
    DRUG
  4. arm Group Labels
    1. autologous stem cell transplant
    description
    Given IV or PO
    name
    cyclophosphamide
    other Names
    1. CPM
    2. CTX
    3. Cytoxan
    4. Endoxan
    5. Endoxana
    type
    DRUG
  5. arm Group Labels
    1. autologous stem cell transplant
    description
    Given IV
    name
    etoposide
    other Names
    1. EPEG
    2. VP-16
    3. VP-16-213
    type
    DRUG
  6. arm Group Labels
    1. autologous stem cell transplant
    description
    Given IV
    name
    bortezomib
    other Names
    1. LDP 341
    2. MLN341
    3. VELCADE
    type
    DRUG
  7. arm Group Labels
    1. autologous stem cell transplant
    description
    Given PO
    name
    thalidomide
    other Names
    1. Kevadon
    2. Synovir
    3. THAL
    4. Thalomid
    type
    DRUG
  8. arm Group Labels
    1. autologous stem cell transplant
    description
    Given IV
    name
    melphalan
    other Names
    1. Alkeran
    2. CB-3025
    3. L-PAM
    4. L-phenylalanine mustard
    5. L-Sarcolysin
    type
    DRUG
  9. arm Group Labels
    1. autologous stem cell transplant
    name
    autologous stem cell transplant
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
41
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value.
    measure
    Median Progression Free Survival (mPFS)
    time Frame
    From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
  2. description
    Percentage of participants with severe complications defined at ICU admission and death, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
    measure
    Percentage of Participants With Serious Treatment-Related Complications
    time Frame
    From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.
  3. description
    Percentage of participants able to complete the full course of therapy.
    measure
    Percentage of Participants Able to Complete Full Course Therapy
    time Frame
    Up to 6 years
secondary Outcomes
  1. description
    Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.
    measure
    Mean Change in Quality-Of-Life Indicators Post-Transplant
    time Frame
    Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.
Full study description
brief 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 .
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice