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NCT00215943 · REGISTRY CONDITION SEARCH

Phase III Randomized Trial of Thalidomide/Dexamethasone Versus Vincristine+Adriamycin+Dexamethasone (VAD)

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

Phase
PHASE3
Status at capture
TERMINATED
Registry last update
2014-04-17

Investigators planned to accrue 176 participants, to compare the response rate, overall response rate and survival of patients with multiple myeloma (MM) when randomized to two regimens (thalidomide+Dexamethasone versus Vincristine+Adriamycin+Dexamethasone). Investigators also planned to test if treatment with zoledronate immediately prior to chemotherapy results in an enhanced response to treatment (i.e. increase in complete response rates).

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

Response Rates of VAD vs. Thalidomide/Dexamethasone

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outcome · POSTED

Number of Participants With Adverse Events, by Group

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outcome · POSTED

Number of Participants With Progression Free Survival (PFS), by Treatment Arm

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outcome · POSTED

Overall Survival (OS), by Treatment Arm

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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: * Patients must have newly diagnosed MM confirmed by the presence of bone marrow plasmacytosis with \> 10 percent plasma cells, sheets of plasma cells, or biopsy-proven plasmacytoma. Patients must have Durie-Salmon Stage IIA-B or IIIA-B. Patients with non-secretory myeloma are eligible. (These patients will not be included in the analysis of response rates, but will be assessed for toxicity and survival). * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3 * ≥ 18 years of age. * Signed informed consent form * Expected survival of greater than 8 weeks * Capable of swallowing study medication tablets * Capable of following directions regarding taking study medication, or has a daily care provider who will be responsible for administering study medication. * Patients will be eligible for study even if they lack socioeconomic access to autologous transplantation. (These patients will be identified prior to randomization so as not to confound study results). * All patients (in the event that they are randomized to the thalidomide/dexamethasone arm) must agree to take part in the "System for Education and Prescribing Safety" (S.T.E.P.S.)™. They must sign a separate informed consent for this program. Exclusion Criteria: * Elevated direct bilirubin \> 2 mg/dl * Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) \> 2 times the upper limit of normal (ULN) * Absolute neutrophil count (ANC) \<1000/mL, unless felt to be secondary to myeloma * Ongoing radiation therapy, or radiation therapy within 3 weeks prior to first treatment, unless the acute side effects associated with such therapy are resolved. * Prior treatment for multiple myeloma * Prior bisphosphonate use is allowed but they must be discontinued before starting treatment. * Concurrent uncontrolled serious infection * Patients with peripheral (sensory) neuropathy, grade 3 or higher * Life-threatening illness (unrelated to tumor) * History of any other ACTIVE and INVASIVE cancer other than the present condition (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years. * Women of childbearing potential (unless utilizing birth control) or who are pregnant or nursing will be excluded from this study. * Patients with comorbid conditions that would contraindicate the use of vincristine, doxorubicin, dexamethasone, thalidomide, or zoledronate. * Plasma Cell Leukemia
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one "cycle" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle.
    intervention Names
    1. Drug: zoledronic acid
    2. Drug: vincristine
    3. Drug: adriamycin
    label
    VAD Treatment
    type
    ACTIVE_COMPARATOR
  2. description
    Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
    intervention Names
    1. Drug: zoledronic acid
    2. Drug: dexamethasone
    3. Drug: thalidomide
    label
    Thalidomide and Dexamethasone Treatment
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Thalidomide and Dexamethasone Treatment
    2. VAD Treatment
    description
    Patients were randomized to receive zoledronic acid I.V. on either Day 1 or 15 of each cycle. This schedule continued monthly as long as the patient remained on study. The dose was calculated based on the patients' monthly creatinine clearance.
    name
    zoledronic acid
    other Names
    1. Zometa®
    2. Zoledronate
    type
    DRUG
  2. arm Group Labels
    1. Thalidomide and Dexamethasone Treatment
    description
    As outlined in VAD Treatment arm and Thalidomide and Dexamethasone Treatment arm
    name
    dexamethasone
    other Names
    1. Decadron
    2. NSC-34521
    type
    DRUG
  3. arm Group Labels
    1. Thalidomide and Dexamethasone Treatment
    description
    As outlined in Thalidomide and Dexamethasone Treatment arm
    name
    thalidomide
    other Names
    1. Thalomid™
    type
    DRUG
  4. arm Group Labels
    1. VAD Treatment
    description
    As outlined in VAD Treatment Arm
    name
    vincristine
    other Names
    1. Oncovin
    2. NSC-67574
    type
    DRUG
  5. arm Group Labels
    1. VAD Treatment
    description
    As outlined in VAD Treatment arm
    name
    adriamycin
    other Names
    1. Doxorubicin
    2. NSC-123127
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
90
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Blade (15) criteria for remission in multiple myeloma was used to assess response. Complete Response (CR)includes: Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of 6 weeks by immunofixation studies. Partial Response (PR) includes: At least a 50% reduction in the level of serum monoclonal protein for at least two determinations 6 weeks apart. Minimal Response (MR)includes: At least a 25% to 49% reduction in the level of serum monoclonal protein for at least 2 determinations 2 weeks apart.
    measure
    Response Rates of VAD vs. Thalidomide/Dexamethasone
    time Frame
    End of Cycle 4 - 4 Months per Participant
secondary Outcomes
  1. description
    Number of participants with toxicities of Thalidomide/Dexamethasone vs. VAD as induction regimens in newly diagnosed multiple myeloma (MM).
    measure
    Number of Participants With Adverse Events, by Group
    time Frame
    4 Years, 7 Months
  2. description
    Number of participants with PFS for thalidomide/Dexamethasone vs. VAD with respect to progression free survival in newly diagnosed MM. Progressive Disease (PD): (for patients not in CR) Requires one or more of the following; \> 25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. \> 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg and confirmed on a repeat investigation. \>25% increase in plasma cells in a bone marrow aspirate, which also must be an absolute increase of at least 10%. Definite increase in the size of existing lytic lesions or plasmacytomas. Development of new bone lesions or plasmacytomas (except compression fractures). Development of hypercalcemia (corrected calcium \> 11.5 mg/dL not attributable to other causes).
    measure
    Number of Participants With Progression Free Survival (PFS), by Treatment Arm
    time Frame
    4 Months
  3. description
    Median OS for thalidomide/Dexamethasone participants vs. VAD participants. Months from On Study to Expired/Last Date Known Alive. Investigators had planned to accrue 176 participants to calculate median overall survival.
    measure
    Overall Survival (OS), by Treatment Arm
    time Frame
    Up to 10 Years
Full study description
brief Summary
Investigators planned to accrue 176 participants, to compare the response rate, overall response rate and survival of patients with multiple myeloma (MM) when randomized to two regimens (thalidomide+Dexamethasone versus Vincristine+Adriamycin+Dexamethasone). Investigators also planned to test if treatment with zoledronate immediately prior to chemotherapy results in an enhanced response to treatment (i.e. increase in complete response rates).
detailed Description
Patients Randomized to receive VAD (vincristine, adriamycin, dexamethasone): All patients received four cycles of VAD repeated every 4 weeks. Chemotherapy was administered by continuous IV Infusion for 96 hours: vincristine at a dose of 0.4 mg/day and doxorubicin at a dose of 9 mg/m\^2/day. Patients were administered dexamethasone 40 mg by mouth (PO) on days 1 to 4, 9 to 12, and 17 to 20 of the initial two cycles. Dexamethasone was given only on days 1-4 of all subsequent cycles. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle. This schedule continued monthly as long as the patient remained on study. The dose was calculated based on the patients' monthly creatinine clearance. Upon initiation of Zometa therapy, the following guidelines were applied: For patients with creatinine clearance \>60 mL/min, the recommended dose remained at 4mg. For patients with reduced creatinine clearance, dosing was calculated to achieve the same area under curve (AUC) as in patients with creatinine clearance of 75 mL/min. Creatinine clearance was calculated using the Cockcroft-Gault formula.
Source references
Source notices and limitations
    Discovery and provenance
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        exact text
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice