NCT00719901 · REGISTRY CONDITION SEARCH

Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory 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: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2015-01-12

This phase I/II trial is studying the side effects and best dose of obatoclax when given together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma. Obatoclax and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obatoclax together with bortezomib may kill more cancer cells.

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

Number of Dose-limiting Toxicity (DLT) Incidents (Phase I)

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outcome · POSTED

Proportion of Patients Who Achieve a Partial Response or Better. (Phase II)

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outcome · POSTED

Number of Patients Who Have at Least a Partial Response (Phase I)

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outcome · POSTED

Time to Progression (Phase II)

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outcome · POSTED

Overall Survival (Phase II)

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outcome · POSTED

Time to Treatment Failure (Phase II)

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outcome · POSTED

Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II)

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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: * Symptomatic multiple myeloma, meeting the following criteria at original diagnosis: * Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma * Symptomatic disease (e.g.,anemia, hypercalcemia, bone disease, or renal dysfunction) that requires the initiation of therapy * Measurable diseases assessed by one of the following: * Monoclonal plasma cells detectable in the bone marrow * Monoclonal serum spike detectable by serum protein electrophoresis or immunofixation * Monoclonal protein detectable in the urine by electrophoresis or immunofixation * Abnormal levels of the serum free light chains with an abnormal ratio between kappa and lambda * Progressive disease after ≥ 1 prior therapy for myeloma * Previously treated with ≤ 10 courses (30 weeks) of bortezomib and had no disease progression during therapy OR completed bortezomib therapy within the past 6 weeks * No prior discontinuation of bortezomib therapy due to drug intolerance * No known brain metastases * No intracranial edema, intracranial metastasis, or active epidural disease * Patients with lytic lesions of the cranium secondary to myeloma are eligible * ECOG performance status 0-2 * Life expectancy \> 6 months * ANC ≥ 1,000/mm³ * Platelet count ≥ 50,000/mm³ * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Creatinine ≤ 2 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No peripheral neuropathy \> NCI toxicity grade 2 * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to obatoclax mesylate or bortezomib * No concurrent uncontrolled illness including, but not limited to the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia, including QTc \> 450 msec * Psychiatric illness/social situations that would limit compliance with study requirements * No history of seizure disorder * No other neurological disorder or dysfunction that, in the opinion of the investigator, would confound the evaluation of neurologic and other adverse events associated with obatoclax mesylate * At least 14 days since prior chemotherapy and recovered * More than 28 days since prior experimental drugs and/or investigational agents * No concurrent CYP interactive medications * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer therapy * Growth factors and bisphosphonates are allowed as medically indicated * Prednisone (≤ 10 mg per day) allowed provided there has been no dose increase within the past 2 weeks * No other concurrent investigational agents
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive obatoclax mesylate IV over 3 hours and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
intervention Names
Drug: obatoclax mesylate
Drug: bortezomib
Other: laboratory biomarker analysis
label
Treatment (enzyme inhibitor therapy)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (enzyme inhibitor therapy)
description
Given IV
name
obatoclax mesylate
other Names
GX15-070MS
type
DRUG
arm Group Labels
Treatment (enzyme inhibitor therapy)
description
Given IV
name
bortezomib
other Names
LDP 341
MLN341
VELCADE
type
DRUG
arm Group Labels
Treatment (enzyme inhibitor therapy)
description
Correlative studies
name
laboratory biomarker analysis
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 11
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
DLT was defined as any events that is determined to be possibly, probably, or definitely related to the combination of bortezomib and GX15-070 (as determined by the investigator) and occurring during the first cycle of treatment, irrespective of whether the toxicity resolved. Hematologic DLT measures were assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via Common Terminology Criteria for Adverse Events (CTCAE) version 3 standard toxicity grading.
measure
Number of Dose-limiting Toxicity (DLT) Incidents (Phase I)
time Frame
Up to 21 days of every first course
description
In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.
measure
Proportion of Patients Who Achieve a Partial Response or Better. (Phase II)
time Frame
From baseline to up to 3 years

secondary Outcomes

description
In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.
measure
Number of Patients Who Have at Least a Partial Response (Phase I)
time Frame
From baseline to up to 3 years
description
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
measure
Time to Progression (Phase II)
time Frame
Time from registration to the time of progression
description
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
measure
Overall Survival (Phase II)
time Frame
Time from registration to death due to any cause
description
Time to treatment failure will be evaluated using the method of Kaplan-Meier.
measure
Time to Treatment Failure (Phase II)
time Frame
Time from study entry to the date patients end treatment
description
Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, we will review all toxicities data that is graded as 3, 4, or 5 and classified as either "unrelated or unlikely to be related" to study treatment in the event of an actual relationship developing. Adverse events and toxicities will be evaluated using all patients who have received any study treatment.
measure
Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II)
time Frame
From baseline to up to 3 years

Full study description

brief Summary: This phase I/II trial is studying the side effects and best dose of obatoclax when given together with bortezomib and to see how well they work in treating patients with relapsed or refractory multiple myeloma. Obatoclax and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obatoclax together with bortezomib may kill more cancer cells.
detailed Description: PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose and recommended phase II dose of obatoclax mesylate when given in combination with bortezomib in patients with relapsed or refractory multiple myeloma. (Phase I) II. To evaluate the response rate (complete response, partial response, and very good partial response) in patients treated with this regimen. (Phase II) SECONDARY OBJECTIVES: I. To determine the duration of progression-free and overall survival of these patients. II. To evaluate the incidence of toxicities of this regimen in these patients. III. To explore the utility of genetic markers based on initial evidence that they are predictive of drug responsiveness and/or successful target inhibition. OUTLINE: This is a multicenter, phase I, dose-escalation study of obatoclax mesylate followed by a phase II study. Patients receive obatoclax mesylate IV over 3 hours and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years.

Source references

Source notices and limitations

Discovery and provenance

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primary nct id
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source kind
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exact text
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query cond
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query disease state id
ds-plasma-cell-neoplasms
source file
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source string sha256
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source url
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Preserved source evidence · Not medical advice