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A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03288480
Recruitment Status : Active, not recruiting
First Posted : September 20, 2017
Last Update Posted : July 24, 2020
Information provided by (Responsible Party):
Phosplatin Therapeutics

Brief Summary:

Study PT-112-102, a multicenter, open-label dose-finding and pharmacokinetic study of PT-112 in patients with relapsed or refractory multiple myeloma.

This is designed as a two-part study. In the first part of the study, cohorts of three patients (expanded to six patients in the event of a dose-limiting toxicity) will receive escalating doses of PT-112 until the MTD is reached, based on tolerability observed during the first 28 days of treatment. In the second part of the study, an expansion cohort of 14 patients will be treated at the recommended dose to confirm the tolerability of treatment and evaluate evidence of treatment efficacy.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: PT-112 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This is a multicenter, open-label study of PT-112 in patients with relapsed or refractory MM. The study will be conducted in two parts:

Part 1: Dose escalation Part 2: Dose expansion

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
This is a single arm study of PT-112, which is administered to patients with relapsed or refractory MM
Drug: PT-112
This is a single arm study

Primary Outcome Measures :
  1. Recommended dose (RD) of PT-112 for further studies in patients with relapsed or refractory multiple myeloma (MM) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: 18 months ]
  2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 18 months ]
  3. Dose-limiting toxicities (DLTs) [ Time Frame: 18 months ]
  4. Number of patients with Adverse Events (AEs) [ Time Frame: 18 months ]
    Characterization of the type, incidence, severity, duration, reversibility and relationship to treatment of adverse events (AEs), and effects on vital signs and laboratory parameters.

  5. Tumor response, including assessment of minimal residual disease, according to the International Myeloma Working Group (IMWG) response criteria [ Time Frame: 18 months ]
  6. Duration of response [ Time Frame: 18 months ]
  7. Progression free survival [ Time Frame: 18 months ]
  8. Relationship between sensitivity/response to treatment and disease status including cytogenetic biomarkers [ Time Frame: 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Previously diagnosed with MM requiring treatment based on IMWG diagnostic criteria;
  2. Relapsed or refractory MM after adequate exposure to and therapeutic response (following IMWG response criteria) to at least one line of treatment with one or more active agents, including alkylating drugs, corticosteroids, immunomodulatory drugs (IMiD: thalidomide, lenalidomide, pomalidomide), proteasome inhibitors (bortezomib, cartilzomib), and monoclonal antibodies (daratumumab, elotuzumab, ixazomab);
  3. Evaluable MM with at least one of the following: (a) serum monoclonal component ≥ 0.5 g/dL; or (b) Bence Jones (BJ) proteinuria ≥ 200 mg/24h; or (c) measurable plasmacytoma (not previously irradiated); or (d) involved serum free light chain ≥ 10 mg/dL with an abnormal free light chain ratio;
  4. ECOG Performance Status (PS) 0-2;
  5. Life expectancy > 3 months;
  6. At least 2 weeks (or 5 half-lives, whichever is longer) wash-out since the end of previously administered experimental therapy (6 weeks if previous nitrosourea containing regimen) or 2 weeks for standard-of-care regimens. Concurrent corticosteroids are allowed provided they are administered at an equivalent prednisone dose of ≤ 10 mg/day, as prediction or blood products only;
  7. Recovery from non-hematologic toxic effects of prior therapy to grade ≤ 1 (except alopecia) by NCI CTCAE Version 4.03;
  8. Adequate bone marrow (BM), renal, hepatic and metabolic function.

Key Exclusion Criteria:

  1. Any of the following concomitant diseases/conditions:

    • History or presence of myocardial infarction, clinically relevant valvular heart disease, or congestive heart failure within the last 12 months;
    • Unstable cardiac dysrhythmias or persistent prolongation of the corrected QT interval (QTc) (Fridericia) to >480 msec for males or >500 msec for females, based on ECG at screening (patients with stable atrial fibrillation on treatment are allowed provided they do not meet any other cardiac or prohibited drug exclusion criterion);
    • Presence of current angina;
    • Active uncontrolled infection;
    • Morphological or cytological features of myelodysplasia and/or post-chemotherapy aplasia on BM assessment;
    • Myopathy > grade 2 or any clinical situation that causes significant and persistent elevation of CPK (>2.5 x ULN in two different determinations performed one week apart);
    • Peripheral neuropathy > grade 1, except for grade 2 without limitations on instrumental daily life activities;
    • POEMS syndrome or active plasma cell leukemia;
    • Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD;
    • History or presence within the last 3 months of Deep Vein Thrombosis (DVT) or a pulmonary embolism (PE);- Uncontrolled leptomeningeal disease;
    • Uncontrolled disease-related metabolic disorder (e.g., hypercalcemia);
    • Acute or chronic infections requiring systemic therapy, including, among others:
    • active infection requiring systemic therapy;
    • history of testing positive to human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;
    • hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive);
    • active tuberculosis (history of exposure or history of positive TB test with presence of clinical symptoms, physical or radiographic finding);
    • Any other major illness that, in the Investigator's judgment, may substantially increase the risk associated with the patient's participation in this study;
  2. History of prior malignancy other than those previously treated with a curative intent more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated adequately, regardless of the disease-free interval;
  3. Prior irradiation to > 30% of BM reserves (including total body irradiation), regardless of the washout period;
  4. High dose chemotherapy followed by autologous stem cell transplantation within 90 days prior to initiating study treatment;
  5. Bisphosphonate treatment within 7 days prior to initiating study treatment (while on study, bisphosphonates can be administered only once a month, between Days 18 to 21 of the 28-day treatment cycle)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03288480

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United States, Arizona
Mayo Clinic Cancer Center
Phoenix, Arizona, United States, 85054
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80220
United States, Florida
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Oncology San Antonio Medical Center
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Phosplatin Therapeutics
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Principal Investigator: Leif Bergsagel, MD Mayo Clinic
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Responsible Party: Phosplatin Therapeutics Identifier: NCT03288480    
Other Study ID Numbers: PT-112-102
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases