A Phase I Study of Lintuzumab-Ac225 in Patients With Refractory Multiple Myeloma

NCT02998047 | Terminated Phase 1 DMC

• 1 other identifier: Lin-AC225-MM01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 5

Brief Summary

1. 1.Establish the MTD of Lintuzumab-Ac225 as monotherapy
2. 2.Establish overall response rate (ORR) where ORR = CR + sCR+ VGPR+PR)
3. 3.Confirm the safety profile of the treatment regimen
4. 4.Estimate progression-free survival (PFS) and overall survival

Conditions

Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated dose of Lintuzumab-AC225

  establish the maximum tolerated dose as monotherapy

  Through study completion, an average of 2.5 year

• Adverse events- Treatment Emergent

  safety of lintuzumab-Ac225

  Through study completion, an average of 2.5 year

Secondary Outcomes (3)

• Response rates (objective response rate, complete response rate, stringent complete response rate, very good partial response rate and partial response rate)

  Through study completion, an average of 2.5 year

• Progression free survival

  Through study completion, an average of 2.5 year

• Overall survival

  Through study completion, an average of 2.5 year

Study Arms (1)

IV infusion of Lintuzumab AC225

EXPERIMENTAL

Starting dose - 0.5 μCi/Kg IV infusion of Lintuzumab AC225 on Day 1 of each cycle with dose escalation 1 μCi/Kg and 1.5 μCi/Kg or de-escalation to 0.25 μCi/Kg. 1 cycle = 28 days, up to 3 to 8 cycles (depending on the cohort).

Drug: Lintuzumab AC 225

Interventions

Lintuzumab AC 225 DRUG

Lintuzumab-Ac225 is an immunoconjugate \[antibody: anti-CD 33 antibody and radioactive isotope: Actinium (225Ac)\] for the treatment of multiple myeloma.

Also known as: HuM195-Ac225

IV infusion of Lintuzumab AC225

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of multiple myeloma with measurable disease, as defined by the presence of M immunoglobulin protein in serum electrophoresis of at least 0.5 g/dL for IgG or 0.5 g/dL for IgA or urinary excretion of at least 200 mg monoclonal light chain per 24 hours.
• Clinical diagnosis of multiple myeloma requiring treatment that has relapsed after or proven refractory to at least three prior treatment regimens, and in the opinion of the investigator must not be candidates for any FDA approved drug known to provide clinical benefit.
• All acute toxicities from any prior therapy (radiotherapy, chemotherapy, or surgical procedures) resolved to Grade ≤ 2, NCI CTCAE.
• Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal.
• Greater than 25% of myeloma plasmocytes from bone marrow must be CD33 positive.
• Required baseline laboratory data including: White blood cell count, Absolute neutrophil count (ANC), Platelets, Hemoglobin, Serum creatinine, AST, Creatinine clearance, Bilirubin , AST and ALT , FEV1/FVC
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

You may not qualify if:

• Sex and Reproductive Status
• Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least six months (6 months) after the last dose of study medication.
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test on enrollment or prior to investigational product administration.
• Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least six months (6 months) after completion of study medication.
• Target Disease Exceptions
• Concurrent therapy with any other investigational agent.
• Concomitant therapy with bisphosphonates.
• Pathological fracture within 3 months prior to treatment;
• Symptomatic spinal cord compression; .
• Medical History and Concurrent Diseases
• Treatment with chemotherapy or biological therapy 3 weeks prior to enrollment;
• Presence of HAHA on screening
• No bone marrow transplant within 3 months prior to treatment initiation
• Prior treatment with radiation to cumulative maximum tolerated dose

Sponsors & Collaborators

• Actinium Pharmaceuticals: lead

Study Sites (5)

UCLA

Los Angeles, California, 90095, United States

Location

University Of Kansas Medical Center

Kansas City, Kansas, 66205, United States

Location

Memorial Sloan Kettering Cancer CEnter

New York, New York, 10065, United States

Location

Baylor Scott and White Research Institute, Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

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

Study Officials

• Avinash Desai, MD

  Actinium Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 20, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)