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

NCT02658396 | Withdrawn Phase 1 DMC

• 1 other identifier: 15-363
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Multiple Myeloma; Multiple Myeloma in Relapse; Refractory Multiple Myeloma

Keywords

Multiple Myeloma; Relapsed Multiple Myeloma; Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• MTD Dose

  Baseline to 21 Days

Secondary Outcomes (4)

• Response Rate

  12 Months

• Progression Free Survival

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

• Event Free Survival

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

• Time-to-new treatment

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

Study Arms (1)

GO-203-2C

EXPERIMENTAL

* 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

Drug: GO-203-2C; Drug: Bortezomib

Interventions

GO-203-2C DRUG

GO-203-2C

Bortezomib DRUG

Also known as: Velcade

GO-203-2C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Genus Oncology, LLC: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jacalyn Rosenblatt, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 18, 2016
• Primary Completion: May 1, 2019
• Study Completion: January 1, 2022
• Last Updated: July 5, 2017

Record last verified: 2017-06

Locations

US (2)