Talquetamab & Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma, Post Stem Cell Transplant

In brief

Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.

Key facts

Study ID

NCT06461988

Run by

Stanford University

People needed

20

Starts

2025-06-05

Expected to finish

2029-12-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have had a confirmed diagnosis of symptomatic multiple myeloma according to according to IMWG diagnostic criteria.
• Measurable disease at the time of myeloma diagnosis Measurable disease is defined as measurable M protein in the serum (≥ 0.5g/dL) or urine (≥ 200 mg/24h) or serum free light chain assay (defined as dFLC ≥ 10 mg/dL [≥ 100 mg/L]; difference between involved and uninvolved free light chain) at the time of diagnosis. Participants with smoldering myeloma are not eligible until they have progressed to symptomatic myeloma. Participants with purely non-secretory MM at the time of diagnosis as measured by electrophoresis and immunofixation and the absence of Bence Jones proteins in the urine are not eligible.
• Age >18 years.
• Patients who have already received transplant should have undergone autologous stem cell transplant with Melphalan 140 mg/m2 within 12 months of start of induction therapy of multiple myeloma and are within day +60-120 post-transplant. Patients who have not already received transplant must have begun induction therapy within 12 months prior to the planned date of transplant.
• Participants must not be refractory to lenalidomide
• Participants must not have progressive disease at any time prior to registration
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment:
• Hemoglobin: ≥ 8 g/dL (≥ 4.96 mmol/L; without transfusion support or erythropoietin use within 7 days before the laboratory test)
• Platelets: ≥ 75×109/L in participants in whom <50% of bone marrow nucleated cells are plasma cells and ≥ 50×109/L in participants in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test)
• Absolute neutrophil count: ≥ 1.0×109/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated GCSF before the laboratory test)
• AST and ALT: ≤2.5×ULN
• Creatinine clearance: ≥30 mL/min based on Cockcroft Gault equation
• Total bilirubin: ≤2.0×ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5×ULN is required)
• Serum calcium corrected for albumin: ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL
• (ALT=alanine aminotransferase; AST=aspartate aminotransferase; GCSF=granulocyte colony stimulating factor; GM-CSF=granulocyte-macrophage colony stimulating factor; RBC=red blood cell; ULN=upper limit of normal)
• A woman of childbearing potential must have a negative highly sensitive urine or serum (β human chorionic gonadotropin [β hCG]) pregnancy test at screening, again a negative serum test within 48 hours prior to the start of study treatment.
• A woman must be:
• Not of childbearing potential, or
• Of childbearing potential and 1) Practicing true abstinence; or 2) Have a sole partner who is bilaterally vasectomized; or 3) Practicing 2 effective methods of contraception (at least 1 highly-effective, method of contraception (see 3 for methods of contraception allowed).
• NOTE: Participant must agree to continue the above throughout the study and for 100 days after the last dose of study treatment.
• NOTE: If a woman becomes of childbearing potential after start of the study the woman must comply with point (b) as described above. If a participant's reproductive status is questionable, additional evaluation should be considered.
• NOTE: An interaction between hormonal contraception and talquetamab has not been formally studied. Therefore, it is unknown whether talquetamab may reduce the efficacy of the contraception method. If a woman is receiving talquetamab and is using hormonal contraceptives, an additional barrier method must be used.
• NOTE: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
• A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 100 days after receiving the last dose of study treatment

You may not qualify if…

• Intolerance to lenalidomide 10 mg (or 5 mg for patients with creatinine clearance 30-60 ml/min).
• Refractory or relapsed multiple myeloma at any time before enrollment
• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the talquetamab Investigator's Brochure and appropriate package inserts).
• Prior or concurrent exposure to any of the following, in the specified time frame as defined below:
• a. Received any prior GRPRCD5-directed therapy b. Received prior T-cell redirection therapy (for example, antibody therapy or BiTE's) or Chimeric antigen T cell therapy.
• b. Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
• c. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less
• d. Investigational vaccine other than SARS CoV-2 vaccine approved/ in use under emergency approval within 4 weeks
• e. Live, attenuated vaccine within 4 weeks.
• f. Monoclonal antibody therapy targeting multiple myeloma within 21 days
• g. Cytotoxic therapy within 21 days i PI therapy within 14 days
• h. IMiD agent therapy within 14 days
• i. Radiotherapy within 14 days or focal radiation within 7 days
• A maximum cumulative dose of corticosteroids of ≥ 140 mg of prednisone or equivalent within 14-day period before the first dose of study drug (does not include pretreatment medications) (Section 13.8, Appendix 8)
• Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
• Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis.
• Myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than relapsed/refractory multiple myeloma. The only allowed exceptions are:
• Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured
• Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.
• Noninvasive cervical cancer treated within the last 24 months that is considered completely cured
• Localized prostate cancer (N0M0):
• With a Gleason score of ≤7a, treated within the last 24 months, or untreated and under surveillance 2. With a Gleason score of 3+4 that has been treated >6 months prior to full study screening and considered to have a very low risk of recurrence, or e). History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.
• f) Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence g) Other malignancy that is considered cured with minimal risk of recurrence.
• Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF.
• Participant is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 100 days after the last dose of study treatment.

Where it is running

• Stanford University — Palo Alto, California, United States (enrolling)

Full record on ClinicalTrials.gov

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