Multiple MyelomaPhase 2UltraDexNCT02402725
A Open-label Study of Ultra-High Dose Dexamethasone for Relapsed Multiple Myeloma
A Phase 2 study testing Dexamethasone in people with Multiple Myeloma, run by Boston Medical Center at 1 site in United States.
Trial summary
This is a phase II, open label, single-center study of ultra-high dose dexamethasone administered intravenously and orally as monotherapy for the treatment of relapsed multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed multiple myeloma (MM) with measurable disease parameters according to the International Myeloma Working Group (IMWG) Criteria for the Diagnosis of Multiple Myeloma
- Relapsed is defined as the development of disease progression following the achievement of stable disease (SD), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) to the most recent anti-myeloma regimen
- Received ≥ 2 prior regimen for MM
- The patient or the patient's legal representative is able to understand the risks of the study and provide signed informed consent and authorization to use protected health information (in accordance with national and local privacy regulations)
- ≥18 years of age
- Karnofsky Performance Status score of ≥70
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- Able to adhere to the study visit schedule and other protocol requirements in the Investigator's opinion
- Adequate hepatic function, as evidenced by serum bilirubin values <6.0 mg/dL and serum alanine transaminase (ALT) and/or aspartate transaminase (AST) values <3 × the upper limit of normal (ULN) of the local laboratory reference range. (Patients with isolated elevations in alkaline phosphatase [ALP] <5 × ULN in the presence of bony disease are not excluded from participating in the study)
- If a female participant is of childbearing potential, she must have a negative pregnancy test (urine or serum) at baseline (Cycle 1, Day 0). (A female participant is considered to be NOT of childbearing potential if she has undergone bilateral oophorectomy or if she has been menopausal without a menstrual period for 12 consecutive months)
Who cannot join
- Received any of the following therapies: Radiotherapy within 2 weeks of Cycle 1 Day 1; Systemic therapy within 3 weeks of Cycle 1 Day 1
- Prior peripheral autologous stem cell transplant within 12 weeks of Cycle 1 Day 1
- Prior allogeneic stem cell transplant
- Active systemic infection requiring treatment
- Active malignancy (the following are allowable: patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <0.1 ng/mL; or cervical intraepithelial neoplasia).
- Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status or is known or suspected to have an active hepatitis C infection
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- If female, patient is lactating
- History of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to, patients with:
- Congestive heart failure (New York Heart Association [NYHA] Class 3 or 4
- Unstable angina
- Cardiac arrhythmia
- Recent (within the preceding 6 months) myocardial infarction or stroke
- Hypertension requiring >3 medications for adequate control
- Chronic obstructive pulmonary disease
- History of uncontrolled diabetes mellitus (Type I or II) (Hemoglobin A1C>8.5)
- Any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results
- History of adverse reaction to dexamethasone or other corticosteroids.
- History of allergic reaction attributable to any of the required prophylactic medications (proton pump inhibitor (PPI), fluconazole, trimethoprim-sulfamethoxazole) or reasonable alternative medications
- Inability to monitor glucose at home with glucometer if glucose is found to be abnormal at any study center visit
- Known or suspected AL Amyloidosis
- Currently receiving an investigational agent for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Open-label, Single Center Study of Ultra-High Dose Dexamethasone (UHDD) Administered Intravenously and Orally as Monotherapy for the Treatment of Relapsed Multiple Myeloma
This is a phase II, open label, single-center study of ultra-high dose dexamethasone administered intravenously and orally as monotherapy for the treatment of relapsed multiple myeloma. Dexamethasone has known anti-myeloma activity, and has been studied extensively both alone, and in combination with other agents, in the treatment of multiple myeloma.
This study implements an optimal 2-stage design. In Stage 1, 10 patients will be enrolled. Each patient will receive 100mg of intravenous dexamethasone once on Day 1, immediately followed by 24mg of oral (PO) dexamethasone every 6 hours for 3 days (Days 1-3) in a 28-day cycle. After 4 cycles, the patients will be evaluated for efficacy and safety. If 2 or more of the original 10 patients experience a CR, very good partial response (VGPR), or PR, an additional 20 patients will be enrolled in Stage 2. The enrollment for Stage 2 will occur after the completion of 4 cycles of ultra-high dose dexamethasone. If <2 patients experience a CR, VGPR, or PR, the study will be discontinued. Patients will be treated until progression, intolerable side effects, or death.
The purpose of the proposed phase II study is to determine the overall response rate, progression free survival, and tolerability of "ultra-high" dose dexamethasone.
Read the detailed description
STUDY OBJECTIVES
Primary objective:
- Determine antitumor activity of ultrahigh dose dexamethasone (UHDD) as monotherapy in relapsed multiple myeloma.
Secondary objectives:
- Characterize the safety and tolerability of UHDD as monotherapy in patients with relapsed multiple myeloma.
- Determine the progression free survival amongst responders.
- Determine the subset of patients in whom UHDD can be used as monotherapy for treatment of relapsed multiple myeloma
STUDY ENDPOINTS
Primary endpoint: To determine the anti-tumor activity of UHDD as monotherapy in patients with relapsed multiple myeloma as measured by the International Myeloma Working Group (IMWG) response criteria:
- Change from baseline in M protein component.
- Objective response rate (complete response [CR] + partial response [PR]) assessed according to IMWG response criteria.
- Disease control rate (CR+PR+stable disease [SD]).
Secondary endpoints:
- Safety and tolerability of UHDD
- Progression free survival.
- Characteristics of patients responding to UHDD.
- Conditions
- Multiple Myeloma
- Being tested
- Dexamethasone
- Keywords
- Relapsed Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexamethasone Acetate
(1 cycle = 28 days) D1: Dexamethasone 100mg IV; Dex 24mg PO every 6 hrs (begin immediately after IV dex) D2: Dex 24mg PO every 6 hrs D3: Dex 24mg PO every 6 hrs
| Study group | Role | What they receive |
|---|---|---|
| Ultra-high dose dexamethasone | Experimental | Ultra-high dose dexamethasone administered intravenously and orally Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine antitumor activity of ultrahigh dose dexamethasone (UHDD) as monotherapy in relapsed multiple myeloma.
Measured: 1 year
Secondary outcomes (3)
Characterize the safety and tolerability by assessing the number of related adverse events of UHDD as monotherapy in patients with relapsed multiple myeloma.
Measured: 3 months
Determine the progression free survival amongst responders.
Measured: 5 years
Determine the subset of patients in whom UHDD can be used as monotherapy for treatment of relapsed multiple myeloma
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Mark Sloan, Boston Medical Center
- Investigators
- John M Sloan, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402725
- Sponsor's protocol ID
- H-33781
- Other IDs
- UltraDex
- Acronym
- UltraDex
- Status last verified
- Feb 2017
- First submitted
- 9 Mar 2015
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Single Center Study of Ultra-High Dose Dexamethasone (UHDD) Administered Intravenously and Orally as Monotherapy for the Treatment of Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02402725
- Acronym / sponsor ID
- UltraDex / H-33781
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, open label, single-center study of ultra-high dose dexamethasone administered intravenously and orally as monotherapy for the treatment of relapsed multiple myeloma. Dexamethasone has known anti-myeloma activity, and has been studied extensively both alone, and in combination with other agents, in the treatment of multiple myeloma.
This study implements an optimal 2-stage design. In Stage 1, 10 patients will be enrolled. Each patient will receive 100mg of intravenous dexamethasone once on Day 1, immediately followed by 24mg of oral (PO) dexamethasone every 6 hours for 3 days (Days 1-3) in a 28-day cycle. After 4 cycles, the patients will be evaluated for efficacy and safety. If 2 or more of the original 10 patients experience a CR, very good partial response (VGPR), or PR, an additional 20 patients will be enrolled in Stage 2. The enrollment for Stage 2 will occur after the completion of 4 cycles of ultra-high dose dexamethasone. If <2 patients experience a CR, VGPR, or PR, the study will be discontinued. Patients will be treated until progression, intolerable side effects, or death.
The purpose of the proposed phase II study is to determine the overall response rate, progression free survival, and tolerability of "ultra-high" dose dexamethasone.
Detailed description
STUDY OBJECTIVES
Primary objective:
- Determine antitumor activity of ultrahigh dose dexamethasone (UHDD) as monotherapy in relapsed multiple myeloma.
Secondary objectives:
- Characterize the safety and tolerability of UHDD as monotherapy in patients with relapsed multiple myeloma.
- Determine the progression free survival amongst responders.
- Determine the subset of patients in whom UHDD can be used as monotherapy for treatment of relapsed multiple myeloma
STUDY ENDPOINTS
Primary endpoint: To determine the anti-tumor activity of UHDD as monotherapy in patients with relapsed multiple myeloma as measured by the International Myeloma Working Group (IMWG) response criteria:
- Change from baseline in M protein component.
- Objective response rate (complete response [CR] + partial response [PR]) assessed according to IMWG response criteria.
- Disease control rate (CR+PR+stable disease [SD]).
Secondary endpoints:
- Safety and tolerability of UHDD
- Progression free survival.
- Characteristics of patients responding to UHDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultra-high dose dexamethasone | Experimental | Drug: DexamethasoneUltra-high dose dexamethasone administered intravenously and orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Relapsed multiple myeloma (MM) with measurable disease parameters according to the International Myeloma Working Group (IMWG) Criteria for the Diagnosis of Multiple Myeloma
- Relapsed is defined as the development of disease progression following the achievement of stable disease (SD), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) to the most recent anti-myeloma regimen
- Received ≥ 2 prior regimen for MM
- The patient or the patient's legal representative is able to understand the risks of the study and provide signed informed consent and authorization to use protected health information (in accordance with national and local privacy regulations)
- ≥18 years of age
Key exclusion criteria (21 listed)
- Received any of the following therapies: Radiotherapy within 2 weeks of Cycle 1 Day 1; Systemic therapy within 3 weeks of Cycle 1 Day 1
- Prior peripheral autologous stem cell transplant within 12 weeks of Cycle 1 Day 1
- Prior allogeneic stem cell transplant
- Active systemic infection requiring treatment
- Active malignancy (the following are allowable: patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <0.1 ng/mL; or cervical intraepithelial neoplasia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Dexamethasone Acetate(1 cycle = 28 days) D1: Dexamethasone 100mg IV; Dex 24mg PO every 6 hrs (begin immediately after IV dex) D2: Dex 24mg PO every 6 hrs D3: Dex 24mg PO every 6 hrs | Drug | Ultra-high dose dexamethasone |
Primary outcome
Determine antitumor activity of ultrahigh dose dexamethasone (UHDD) as monotherapy in relapsed multiple myeloma.
Time frame: 1 year
3 secondary outcomes
Characterize the safety and tolerability by assessing the number of related adverse events of UHDD as monotherapy in patients with relapsed multiple myeloma.
Time frame: 3 months
Determine the progression free survival amongst responders.
Time frame: 5 years
Determine the subset of patients in whom UHDD can be used as monotherapy for treatment of relapsed multiple myeloma
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Sloan, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone in people with Multiple Myeloma, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine antitumor activity of ultrahigh dose dexamethasone (UHDD) as monotherapy in relapsed multiple myeloma. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.