A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01421186 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MOR03087 phase 1 dose escalation (Drug); MOR03087 (Drug); Dexamethasone (Drug); Pomalidomide (Drug); Lenalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MorphoSys AG
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087 |
16; 16; 16; 16; 16 | — |
| PRIMARY Number of Participants Who Develop Anti-MOR03087 Antibodies |
0; 0; 0; 0; 0 | — |
| SECONDARY Overall Response Rate |
0; 0; 5; 10; 11 | — |
| SECONDARY Time to Progression |
1.1; 2.1; 8.4; 15.9; 33.2 | — |
| SECONDARY Progression-free Survival |
1.1; 2.1; 8.4; 15.9; 26.7 | — |
| SECONDARY Duration of Response |
16.7; 21.2; 32.2 | — |
| SECONDARY Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202 |
137.86; 311.67; 681.53 | — |
| SECONDARY Pharmacokinetics: AUC Cycle 1+2 - Area Under the Time/Concentration Curve for MOR202 |
3307.57; 7970.15; 18178.57 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Male or female subjects 18 years and older
- Relapsed or refractory multiple myeloma defined as:
Parts A, B and C:
(i) Failure of at least 2 previous therapies which must have included an immunomodulatory agent and a proteasome inhibitor (either together or part of different therapies) (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma
Part D:
(i) At least 2 previous therapies including lenalidomide and a proteasome inhibitor (ii) All subjects must have documented progression during or within 60 days after their last prior therapy for multiple myeloma
Part E:
(i) Received at least one previous therapy (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma
- Presence of serum M-protein ≥ 0.5 g per 100 mL (≥ 5 g/L) and / or urine M-protein ≥ 200 mg per 24-hour period
- Absolute neutrophil count (ANC) ≥ 1, 000 / mm3
- Haemoglobin ≥ 8 g/dL
- Ability to comply with all study related procedures, medication use and evaluations
Exclusion Criteria
- Primary refractory multiple myeloma
- History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher
- Treatment with systemic investigational agent within 28 days prior to first study treatment
- Solitary plasmacytoma or plasma cell leukaemia
- Previous allogenic stem cell transplant (SCT)
- Prior therapy with other monoclonal antibodies targeting the CD38 antigen or prior therapy with other IgG monoclonal antibodies within 3 months prior to first study treatment, or IgM monoclonal antibodies within 1 month prior to first study treatment
- Active systemic infection
- Systemic disease preventing study treatment
- Multiple myeloma with central nervous system (CNS) involvement
- Previous treatment with cytotoxic chemotherapy or large field radiotherapy or other myeloma specific therapy within 28 days prior to first study treatment (radiation to a single site as concurrent therapy is allowed)
- Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] classes III, IV)
Data sourced from ClinicalTrials.gov (NCT01421186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.