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Multiple MyelomaPhase 1NCT02658396

GO-203-2C + Bortezomib For Relapsed Or Refractory MM

A Phase 1 study testing GO-203-2C and Bortezomib in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Dana-Farber Cancer Institute at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This research study is studying a combination of targeted therapies known as GO-203-2C and bortezomib as a possible treatment for multiple myeloma that has either progressed or not responded to treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GO-203-2C and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Start not givento Jan 2022
Phase
Phase 1
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

  • Participants with multiple myeloma who experienced disease progression after the most recent treatment regimen. Patients must have had prior treatment with a proteasome inhibitor, immunomodulatory drug, and if eligible for transplant an autologous transplant.
  • Patients must have measurable disease, defined as 1 or more of the following:
  • serum M-protein > 0.5 g/dL. For patients with IgA myeloma where the M-protein cannot be quantified on SPEP, total IgA > 0.5 g/dL.
  • Urine M-protein > 200mg/24h
  • serum FLC assay: involved FLC level > 10 mg/dL with abnormal FLC ratio
  • Greater than or equal to 18 years in age
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  • ECOG performance status ≤2 (see Appendix A)
  • Life expectancy of greater than 3 months
  • Participants must have normal organ and marrow function as defined below:
  • leukocytes ≥2,000/mcL
  • platelets ≥50,000/mcL
  • total bilirubin ≤ 2.0 mg/dL (patients with Gilbert syndrome and Bilirubin ≤ 3.5 mg/dL are eligible)
  • AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
  • creatinine ≤ 2 mg/dL
  • --- OR
  • creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  • Women of child-bearing potential must have a documented negative pregnancy test.
  • The effects of GO-203-2c on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of GO-203-2c administration.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Participants who have had chemotherapy or radiotherapy within 14 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 14 days earlier. The use of steroids up the equivalent of 160 mg of dexamethasone is allowed within 14 days of screening, but the last dose has to be given at least 1 day prior to initiation of treatment.
  • Participants who are receiving any other investigational agents.
  • Uncontrolled hypertension. This is defined as sustained blood pressure elevation > 140/90 despite antihypertensive therapy. Patients are allowed to start antihypertensive therapy to meet eligibility criteria; however they have to be on a stable antihypertensive regimen for at least 7 days.
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because GO-203-2c is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GO_203-2c, breastfeeding should be discontinued if the mother is treated with GO-203-2c. These potential risks may also apply to other agents used in this study.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
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  • Hypersensitivity to bortezomib, boron or mannitol.
  • Grade 3 or 4 peripheral neuropathy.
  • Prior discontinuation of a bortezomib-based therapy due to toxicity attributed to bortezomib.
  • Use of G-CSF administration within 7 days of screening
  • Platelet transfusion within 7 days of screening

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Phase I Trial of the MUC1 Inhibitor, GO-203-2c, in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma

This research study is studying a combination of targeted therapies known as GO-203-2C and bortezomib as a possible treatment for multiple myeloma that has either progressed or not responded to treatment.

Read the detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved GO-203-2C as a treatment for any disease.

The FDA (the U.S. Food and Drug Administration) has approved bortezomib as a treatment option for your disease.

The purpose of this research study is to test the safety of GO-203-2C with bortezomib. GO-203-2C is a newly discovered compound that binds to an oncoprotein (a cancer causing protein) called MUC1. Myeloma cells harbor an increased amount of MUC1 on its cell surface. By binding to MUC1, GO-203-2C has been shown to cause tumor cell death in laboratory studies.

Bortezomib is an intravenously or subcutaneously administered medication that belongs to a class of drugs called proteasome inhibitors. Proteasome inhibitors disrupt the normal action of cells that breakdown proteins in both normal and cancer cells. This disruption can stall tumor growth and cause cancer cells to die. Bortezomib is currently approved for the treatment of multiple myeloma.

The Investigators want to find the highest dose of GO-203-2C given in combination with bortezomib that can be administered safely without severe or unmanageable side effects.

Being tested
GO-203-2C, Bortezomib
Keywords
Multiple Myeloma, Relapsed Multiple Myeloma, Refractory 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.

Study groups in NCT02658396
Study groupRoleWhat they receive
GO-203-2CExperimental* Patients who fulfill eligibility criteria will be entered into the trial to receive Bortezomib and GO-203-2C. * After the screening procedures confirm participation in the research study: The investigators are looking for the highest dose of the combination of study drugs that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma, not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated. * Bortezomib * GO-203-2C
Receives: Drug: GO-203-2C; Drug: Bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD Dose

    Measured: Baseline to 21 Days

Secondary outcomes (4)

  1. Response Rate

    Measured: 12 Months

  2. Progression Free Survival

    Estimated using the method of Kaplan and Meier.

    Measured: Start of treatment to disease progression or death from any cause, assessed up to 100 months

  3. Event Free Survival

    Estimated using the method of Kaplan and Meier.

    Measured: Time of treatment initiation to Progressive Disease, death, or nonprotocol therapy, assessed up to 100 months

  4. Time-to-new treatment

    Estimated using the method of Kaplan and Meier.

    Measured: From treatment initiation to next treatment or death of any cause, assessed up to 100 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2016 (estimated)
  2. Primary completionMay 2019 (estimated)
  3. Study completionJan 2022 (estimated)

Why it stopped: Study was never open due to lack of funding

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02658396
Sponsor's protocol ID
15-363
Status last verified
Jun 2017
First submitted
13 Jan 2016
Last updated
5 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GO-203-2C and Bortezomib in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Dana-Farber Cancer Institute at 2 sites 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 19 inclusion and 11 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

MTD Dose (time frame: Baseline to 21 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02658396.

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 5 Jul 2017.

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