Study Description

Brief summary:

Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

• Condition or Disease:Multiple Myeloma
• Intervention/Treatment: Drug: CC-93269
• Phase: Phase 1

Detailed Description

The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 2 years or extended up to 5 years for subjects maintaining clinical benefit at the discretion of the Safety Review Committee, until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.

Study Design

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. Adverse Events (AEs) [ Time Frame: Up to 60 months ]
  Number of participants with Adverse Events
• Primary Outcome Measures: 2. Dose Limiting Toxicity (DLT) [ Time Frame: Up to 60 months ]
  Is defined as any of the toxicities occurring within the DLT assessment window (Cycle 1, Days 1 to 28) except those that are clearly and incontrovertibly due to extraneous causes.
• Primary Outcome Measures: 3. Non-Tolerated Dose (NTD) [ Time Frame: Up to 60 months ]
  Is defined as a dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in the DLT window.
• Primary Outcome Measures: 4. Maximum Tolerated Dose (MTD) [ Time Frame: Up to 60 months ]
  Is defined as the last dose cohort below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during the DLT window.
• Secondary Outcome Measures: 1. Overall Response Rate (ORR) [ Time Frame: Up to 60 months ]
  Is defined as the proportion of subjects who achieve a partial response or better (eg, PR, VGPR, CR or sCR), according to International Myeloma Working Group (IMWG) response criteria.
• Secondary Outcome Measures: 2. Time to Response [ Time Frame: Up to 60 months ]
  Is defined as the time from the first CC-93269 dose date to the date of first documented response (PR or better).
• Secondary Outcome Measures: 3. Duration of Response [ Time Frame: Up to 60 months ]
  Is defined as the time from the earliest date of documented response (≥ PR) to the first documented disease progression or death, whichever occurs first.
• Secondary Outcome Measures: 4. Progression Free Survival [ Time Frame: Up to 60 months ]
  Is defined as the time from the first dose of CC-93269 to progressive disease or death from any cause, whichever occurs first.
• Secondary Outcome Measures: 5. Overall Survival [ Time Frame: Up to 60 months ]
  Is defined as the time from the first dose of CC-93269 to death from any cause.
• Secondary Outcome Measures: 6. Pharmacokinetics - Cmax [ Time Frame: Up to 60 months ]
  Maximum serum concentration of drug
• Secondary Outcome Measures: 7. Pharmacokinetics - Cmin [ Time Frame: Up to 60 months ]
  Minimum serum concentration of drug
• Secondary Outcome Measures: 8. Pharmacokinetics - AUC [ Time Frame: Up to 60 months ]
  Area under the curve
• Secondary Outcome Measures: 9. Pharmacokinetics - tmax [ Time Frame: Up to 60 months ]
  Time to peak (maximum) serum concentration
• Secondary Outcome Measures: 10. Pharmacokinetics - t1/2 [ Time Frame: Up to 60 months ]
  Terminal Half-life
• Secondary Outcome Measures: 11. Pharmacokinetics - CL [ Time Frame: Up to 60 months ]
  Apparent total body clearance
• Secondary Outcome Measures: 12. Pharmacokinetics - Vss [ Time Frame: Up to 60 months ]
  Volume of distribution at steady-state
• Secondary Outcome Measures: 13. Pharmacokinetics - accumulation index of alnuctamab [ Time Frame: Up to 60 months ]
  Accumulation ratio of drug
• Secondary Outcome Measures: 14. Presence and frequency of anti-drug antibodies (ADA) [ Time Frame: Up to 60 months ]
  Detection of anti-drug antibodies in participants and frequency of anti-drug antibodies
• Secondary Outcome Measures: 15. Evaluate measures of tumor sensitivity/ resistance to CC-93269 [ Time Frame: Up to 60 months ]
  Measurement of tumor and immune factors

Eligibility Criteria

Information from the National Library of Medicine

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

More Information

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT03486067 History of Changes
• Other Study ID Numbers: CC-93269-MM-001, U1111-1210-6325, 2017-003448-19
• First Posted: April 3, 2018 Key Record Dates
• Last Update Posted: September 16, 2022
• Last Verified: September 2022
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Celgene: Multiple Myeloma
  BCMA X CD3 T Cell
  Antibody CC-93269
  Relapsed and Refractory
• Additional relevant MeSH terms: Multiple Myeloma
  Neoplasms, Plasma Cell
  Neoplasms by Histologic Type
  Neoplasms
  Hemostatic Disorders
  Vascular Diseases
  Cardiovascular Diseases Paraproteinemias
  Blood Protein Disorders
  Hematologic Diseases
  Hemorrhagic Disorders
  Lymphoproliferative Disorders
  Immunoproliferative Disorders
  Immune System Diseases