TriangleNCT00581919 · REGISTRY CONDITION SEARCH
Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated 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
- 2019-12-13
Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily.
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.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Patients with previously treated multiple myeloma with measurable serum or urine monoclonal protein. Exclusion Criteria: * Patients with previous doxorubicin treatment totaling 220 mg/m2 or more * LVEF less than 45% * Patients with \>grade II sensory neuropathy at baseline as assessed by the PI will be excluded * No history of seizures as ALCAR may lower the seizure threshold * Known HIV infection * Current pregnancy.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Bort, Dex, and Dox with ALCAR
- label
- Bort, Dex, and Dox with ALCAR
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Bort, Dex, and Dox with ALCAR
- description
- Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
- name
- Bort, Dex, and Dox with ALCAR
- other Names
- Velcade, cc-5013, ALCAR
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 32
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner. Complete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy. Partial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis.
- measure
- Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR
- time Frame
- Every 21 days, up to 24 weeks
- secondary Outcomes
- measure
- Overall Survival
- time Frame
- From date of randomization until the date of death from any cause, assessed up to 7 years
- description
- Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray.
- measure
- Progression-free Survival
- time Frame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.
Full study description
- brief Summary
- Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily.
- detailed Description
- The primary objective of this study is to assess overall response rate to the treatment. Secondary objectives include: evaluating and describing the incidence of chemotherapy-induced peripheral neuropathy using the FACT/GOG-Ntx assessment tool; evaluating the utility of adding ALCAR to the chemotherapy to reduce the incidence of peripheral neuropathy; and evaluating the utility of the Grooved Pegboard Completion Time as a longitudinal measure of peripheral neuropathy.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-5aed36635aee1df4909b
- requested nct id
- NCT00581919
- primary nct id
- NCT00581919
- source kind
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- source record id
- Source null
- source file sha256
- 2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
- payload sha256
- 29fb06877ac02897e5435ac0f92ee952086aa89f61aab07515ab60e891e748cb
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-5aed36635aee1df4909b
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT00581919
- occurrences
- context exact
- NCT00581919
- end
- 11
- exact text
- NCT00581919
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Plasma Cell Neoplasms
- query disease state id
- ds-plasma-cell-neoplasms
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
- source file sha256
- 2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
- source json pointer
- /studies/311/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 3745d03d841110b55ffb6d4d0c43430e648b8b1deff652bfe925ca9f99f37a56
Preserved source evidence · Not medical advice