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PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03269136
Recruitment Status : Active, not recruiting
First Posted : August 31, 2017
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: PF-06863135 monotherapy IV or SC Drug: PF-06863135 + dexamethasone Drug: PF-06863135 + lenalidomide Drug: PF-06863135 + pomalidomide Phase 1

Detailed Description:
Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two part study; Part 1 will assess the safety and tolerability of increasing dose levels of PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the RP2Ds determined in Part 1.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : April 28, 2023
Estimated Study Completion Date : April 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: PF-06863135
BCMA-CD3 bispecific antibody
Drug: PF-06863135 monotherapy IV or SC
PF-06863135 will be administered intravenously or subcutaneously.
Other Name: BCMA-CD3 bispecific antibody

Experimental: PF-06863135 + dexamethasone
BCMA-CD3 bispecific antibody + dexamethasone
Drug: PF-06863135 + dexamethasone
PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
Other Name: BCMA-CD3 bispecific antibody + dexamethasone

Experimental: PF-06863135 + lenalidomide
BCMA-CD3 bispecific antibody + lenalidomide
Drug: PF-06863135 + lenalidomide
PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
Other Name: BCMA-CD3 bispecific antibody + lenalidomide

Experimental: PF-06863135 + pomalidomide
BCMA-CD3 bispecific antibody + pomalidomide
Drug: PF-06863135 + pomalidomide
PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally
Other Name: BCMA-CD3 bispecific antibody + pomalidomide




Primary Outcome Measures :
  1. Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: At the end of Cycle 1 (each Cycle is 21 or 28 days) ]
    Number of participants with DLTs

  2. To evaluate anti-myeloma activity by objective response rate (ORR) in dose expansion [ Time Frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years) ]
    Percentage of participants with Objective Response Rate (ORR) using the international myeloma working group (IMWG) response criteria for multiple myeloma

  3. To evaluate anti-myeloma activity by duration of response (DOR) in dose expansion [ Time Frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years) ]
    Time from first assessment of partial response or better to last assessment of partial response or better by IMWG criteria


Secondary Outcome Measures :
  1. To evaluate incidence of treatment emergent adverse events and laboratory abnormalities [ Time Frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years) ]
    Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities

  2. To evaluate anti-myeloma activity by objective response rate (ORR) in dose escalation [ Time Frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years) ]
    Percentage of participants with Objective Response Rate (ORR) using the international myeloma working group (IMWG) response criteria for multiple myeloma

  3. To evaluate anti-myeloma activity by time to event endpoints [ Time Frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years) ]
    Time from start date to date of first documentation of event (response or progression by IMWG criteria or death)

  4. To evaluate anti-myeloma activity by duration of event endpoints [ Time Frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years) ]
    Time from first assessment of event endpoint (response or stable disease) to last assessment of (response or stable disease) by IMWG criteria

  5. Impact of treatment on systemic soluble immune factors [ Time Frame: 9 months on treatment ]
    Pre and post dose quantification of soluble cytokines in serum.

  6. Maximum plasma concentration (Cmax) of PF-06863135 [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 (3 to 4 weeks) ]
    Peak concentration of PF-06863135 during first cycle

  7. Trough serum concentrations of PF-06863135 and dexamethasone [ Time Frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years) ]
    Trough serum concentrations of PF-06863135 and dexamethasone at selected cycles

  8. Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135 [ Time Frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years) ]
    AUC of PF-06863135 will be calculated at selected cycles

  9. Incidence and titers of anti-drug antibodies and neutralizing antibodies against PF-06863135 [ Time Frame: From baseline and scheduled timepoints post dose through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years) ]
    Number of participants with the presence of anti-PF-06863135 antibodies



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

Inclusion Criteria:

  • Relapsed/refractory multiple myeloma
  • Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
  • Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma)
  • Adequate bone marrow, hematological, kidney and liver function
  • Resolved acute effects of any prior therapy to baseline severity
  • Not pregnant

Exclusion Criteria:

  • Recent history of other malignancies
  • History of active autoimmune disorders
  • Any form of primary immunodeficiency
  • Active and clinically significant bacterial, fungal, or viral infection
  • Evidence of active mucosal or internal bleeding
  • History of severe immune-mediated adverse event with prior immunomodulatory treatment
  • Major surgery within 4 weeks of study treatment start
  • Radiation therapy within 2 weeks of study treatment start
  • History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
  • Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
  • Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
  • Requirement for systemic immune suppressive medication except as permitted in the protocol
  • Current requirement for chronic blood product support

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 ClinicalTrials.gov identifier (NCT number): NCT03269136


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03269136    
Other Study ID Numbers: C1071001
2019-000822-24 ( EudraCT Number )
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Multiple Myeloma
relapse/ refractory multiple myeloma
bispecific antibody
bispecific
BCMA
BCMA- CD3 bispecific
Phase 1
PF-06863135
dexamethasone
lenalidomide
pomalidomide
Additional relevant MeSH terms:
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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
Thalidomide
Dexamethasone
Dexamethasone acetate
Lenalidomide
Pomalidomide
Antibodies
Immunoglobulins
Antibodies, Bispecific
BB 1101
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents